Primary Outcomes

Description: Changes in task related and resting state BOLD activation.

Measure: Functional MRI

Time: 3 months

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Description: Performance measured using percent correct

Measure: Face-name memory test performance

Time: change from baseline

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Description: Performance measured using deviation from target position

Measure: Object Location Association memory test performance

Time: change from baseline

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Description: Changes in task related and resting state BOLD activation.

Measure: fMRI

Time: change from baseline to 3 months

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Description: Performance measured using percent correct

Measure: Face-name memory test performance

Time: change from baseline to 3 months

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Description: Performance measured using deviation from target position

Measure: Object Location Association memory test performance

Time: change from baseline to 3 months

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Secondary Outcomes

Description: Performance on prose (medical instructions) and spatial (navigation) memory tasks

Measure: Objective memory test performance

Time: 3 months

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Description: Changes on the Multifactorial Memory Questionnaire

Measure: Subjective memory test performance on the MMQ

Time: 3 months

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Description: Performance on prose (medical instructions) and spatial (navigation) memory tasks

Measure: Objective memory test performance

Time: change from baseline to 3 months

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Description: Changes on the Multifactorial Memory Questionnaire

Measure: Subjective memory test performance on the MMQ

Time: change from baseline to 3 months

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Other Outcomes

Description: Planned analyses to examine patient specific characteristics that affect treatment efficacy and would be vital for clinical translation at the individual patient level. These include: Neuropsychological test scores, brain volumes/cortical thickness, and other possible MRI factors.

Measure: Planned (tertiary) analyses of patient-specific characteristics that affect treatment outcome

Time: post treatment (within ~ 96 hours) & 3 months

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Primary Outcomes

Description: A composite measure from the CogTrack battery

Measure: Quality of episodic memory.

Time: Baseline to 24 weeks

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Secondary Outcomes

Description: CogTrack evaluates attentional intensity index, sustained intensity index, cognitive reaction time, attentional fluctuation index, quality of working memory, quality of episodic memory and speed of memory retrieval.

Measure: Secondary endpoints from CogTrack

Time: Baseline to 24 weeks

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Description: Lipid profile, fatty acids, cytokines ( among others: IL-1, IL-2, IL-6, TNF-a), plasma antoxidant status and vitamins (lipid peroxidation markers, vitamins E, C, A, total plasma antioxidant capacity, glutathion)., carinthine, blood glucose, HbA1c, anthocyanins and metabolites, mapping of a-beta degradation products.

Measure: Blood outcome analysis

Time: Baseline to 24 weeks

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Description: Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).

Measure: Cardiovascular parameters

Time: Baseline to 24 weeks

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Description: Microbiota

Measure: Fecal analysis

Time: Baseline to 24 weeks

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Description: kyrinin

Measure: Urine analysis

Time: Baseline to 24 weeks

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Description: anthocyanin metabolites

Measure: CSF measurements

Time: Baseline to 24 weeks

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Description: Diagnosing and follow-up of cerebrovascular disease

Measure: MR-imaging/CT

Time: Baseline to 24 weeks

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Primary Outcomes

Description: Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lowers scores (closest to zero) represent a better outcome.

Measure: Change in Cooking Time Discrepancy Scores

Time: During intervention: baseline, two weeks, and one month

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Description: Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect is the difference between the first and last food item stopped cooking. Lowers scores (closest to zero) represent a better outcome.

Measure: Change in Range of Stop Times Score

Time: During intervention: baseline, two weeks, and one month

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Description: Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests, when finished, one point is given. Higher scores represent a better outcome.

Measure: Change in the Number of Tables Set Score

Time: During intervention: baseline, two weeks, and one month

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Secondary Outcomes

Description: The participants are asked to identify targets and ignore distracting visual information under different conditions. Scores are automatically generated by the software based on the accuracy and reaction time of performance. Higher scores reflect better cognitive ability.

Measure: Transfer to Speed Processing Task (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: Participants are presented with a computer screen of 9 boxes. The boxes light up in a pre-fixed sequence and participants are asked to click on the boxes in the same order they were lit. The sequence length starts at level = 2 boxes and can increase to up to level 9. One point is giving for each correct response. Higher values represent better performance (min 0; max of 16 points).

Measure: Transfer to Visuospatial Working Memory Task (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: Participants are asked to read words and identify letter under different conditions. Scores are based on performance time (seconds) and number of errors.

Measure: Transfer to Inhibitory Control Task (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: Participants listen to series of letters and digits, which they need to organize under specific conditions. One point is giving for each correct response (mix 0; max 30 points).

Measure: Transfer to Verbal Working Memory Task (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: It consists in a test that target three attentional networks involving identifying targets. Lower score represent faster performance.

Measure: Transfer to Complex Attention Task (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: It consist in letters and numbers operations. Accuracy on the alphabetic portion of the Alpha-span task.

Measure: Transfer to Complex Working Memory Task: the Alpha-span task (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: Average z-score computed with outcomes 4 to 9.

Measure: Transfer to Executive Control Composite Score (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Description: Questionnaire listing cognitive failures in everyday life (self-report measure). Higher scores reflect more cognitive failures or difficulties.

Measure: Transfer to self-report cognitive failure questionnaire (Change)

Time: Baseline, two weeks (during the intervention), within one week after the intervention

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Primary Outcomes

Description: Self-reported ability to perform 8 ADLs and 7 IADLs (Range, 0-30; higher scores indicate more functional impairment)

Measure: Change in Precipitating Events Project (PEP) Functional Status Scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Objective measure of lower extremity functioning in older adults (Range, 0-12; higher scores indicate worse lower extremity functioning) The measure will be collected only if in-person contact is possible during the COVID-19 outbreak.

Measure: Change in Short Physical Performance Battery score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Measured using Fitbit

Measure: Change in average step counts from baseline to 2 months for immediate intervention sites; change from 2 to 4 months for waitlist control sites

Time: Measured continuously from 0-4 months

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Description: Measured using Fitbit (minutes spent in each of 4 levels of activity: sedentary; lightly active; fairly active; very active)

Measure: Change in time spent in differing levels of activity from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: 0-4 months

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Description: Self-reported physical activity (Range, 0-793; higher scores indicate greater physical activity)

Measure: Change in Physical Activity Scale for the Elderly (PASE) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: Baseline, 2 months, 4 months for wait-list control

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Secondary Outcomes

Description: Self-reported measure (Range, 13-52; higher scores indicate better quality of life)

Measure: Change in Quality of Life in Alzheimer's Disease (QOL-AD) scale from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Self-reported measure of depressive symptoms (Range, 0-27; higher scores indicate worse depressive symptoms)

Measure: Change in Patient Health Questionnaire (PHQ-9) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: Baseline, 2 months, 4 months for wait-list control

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Description: 14-item self-reported scale (Range, 14-98; higher scores indicate higher levels of resilience)

Measure: Change in Resilience Scale (RS-14) score from baseline to 2 months for immediate intervention sites; change from 2 months to 4 months for waitlist control sites

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Self-reported hospitalization

Measure: Percentage of participants with a hospitalization during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Self-reported number of hospitalizations

Measure: Number of hospitalizations during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Self-reported emergency department visit

Measure: Percentage of participants with an emergency department visit during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Self-reported number of emergency department visits

Measure: Number of emergency department visits during the study period (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Self-reported or emergency contact-reported move to a higher level of care, defined as a move to assisted living, board and care, or nursing home

Measure: Percentage of participants with a move to a higher level of care (baseline to 2 months for immediate intervention sites; 2 months to 4 months for waitlist control sites)

Time: Baseline, 2 months, 4 months for wait-list control

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Description: Assessed using participant responses to invitation to participate in the study (enrolled vs. refused)

Measure: Feasibility of study recruitment, measured as percentage of eligible participants recruited

Time: 0-4 months

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Description: Assessed as percentage of participants who remain enrolled in the study

Measure: Feasibility of study retention, measured as percentage of participants retained over study follow-up

Time: 0-4 months

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Description: Fidelity checklist including each component, with fidelity measured as the percentage of total study protocol tasks completed (Range, 0-100%; higher percentage indicates higher fidelity)

Measure: Percentage fidelity to treatment protocol, measured using fidelity checklist

Time: 0-4 months

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Description: Assessed by psychologist (4 global scores, scored on a 5-point Likert scale from 1 (low) to 5 (high))

Measure: Fidelity to motivational interviewing, measured using the Motivational Interviewing Treatment Integrity Scale (MITI 4)

Time: 0-4 months

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Description: Self-reported acceptability of the intervention (5-point Likert scale ranging from very unacceptable (1) to very acceptable (5); higher numbers indicate higher acceptability)

Measure: Acceptability assessed using a survey question

Time: 0-4 months

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Description: Self-reported acceptability of the intervention assessed using open-ended questions (e.g., "How did the program fit into your life?"; no pre-specified range as responses are qualitative; more positive responses indicate higher acceptability)

Measure: Acceptability assessed using qualitative interviews

Time: 0-4 months

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Primary Outcomes

Description: To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)

Measure: Prevalence of COVID-19 infection in consecutive patients with neurological symptoms

Time: 6 months

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Secondary Outcomes

Description: Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients

Measure: Three months cognitive function of COVID-19 positive patients

Time: 3 months

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Description: Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)

Measure: Clinical presentation of neurological symptoms in COVID-19 positive patients

Time: 6 months

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Description: Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.

Measure: Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients

Time: 6 months

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Description: Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients

Measure: Anosmia in COVID-19 positive patients

Time: 6 months

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Description: Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls

Measure: Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection

Time: 24 months

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Description: Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis

Measure: Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients

Time: 24 months

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Primary Outcomes

Description: The Mini-Mental State Examination (MMSE) (23) will be used to assess the cognitive function of the PMCI/MD. The most common cutoff scores for cognitive impairment and dementia are ranging 23 to 27 over 30. As telephone call interviewing will be the safest means to communicate with the PMCI/MD during and after the COVID-19 pandemic the 22 items telephone version of the MMSE will be used (24). All points of the MMSE can be covered in the telephone version except the last section assessing language and motor skills. In the phone version, we will ask the subject to repeat a phrase and name one item (For example: "Tell me, what is the name of the object you are using to talk to me?"). However, a second item will be not be named, nor will be the person be asked to follow a three-stage command, read and obey a sentence, write a sentence, or copy an intersecting pentagon as in the original version.

Measure: Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Secondary Outcomes

Description: The Quality of Life-Alzheimer's Disease Scale (QoL-AD) (19-22) is an instrument specifically designed to measure QoL in PMCI/MD from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory, and an overall assessment of life quality. Response are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life. When cognitive function may be compromised, informal caregivers will complete the QoL-AD, on behalf of the PMCI/MD.

Measure: Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Description: The European Quality of Life 5 Dimensions 3 Levels (EuroQoL-5D-3L) is a standardized generic instrument consisting of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises 5 dimensions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, moderate problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits can be combined into a 5-digit number that describes the patient's health state. The VAS records the patient's self-rated health on a vertical scale, where the endpoints are 100 = 'The best health you can imagine' and 0 = 'The worst health you can imagine'. EuroQoL-5D-3L has been shown to correlate well with QoL-AD, indicating that using both measures side-by-side is compatible.

Measure: Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Description: The Short Form of the Geriatric Depression Scale (GDS) (25) will be used to assess mood. Of the 15 items, 10 indicate depression when answered positively, while the rest (1, 5, 7, 11, 13) when answered negatively. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 moderate depression, and 12-15 severe depression.

Measure: Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Description: The Instrument for Measuring Older People's Attitudes Toward Technology (TechPH) measures older people's attitudes and enthusiasm for health technology (26). This instrument refers to technophilia as a person's enthusiasm for and positive feelings toward their technology use and absence of the fears and doubts some older people could have about their ability to manage using new technology. The six items of the instrument measure two factors of technophilia: 3 items concerning techEnthusiasm and 3 items techAnxiety. Response are constructed with a five-point Likert scale questionnaire, ranging from 1 (fully disagree) to 5 (fully agree).

Measure: Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Description: The Perceived Stress Scale (PSS) measures the degree to which situations in one's life are appraised as stressful. The scale has 10 questions regarding feelings and thoughts during the last month and are rated according to frecuency 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items

Measure: Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement.

Time: Through study completion, an average of 6 months

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Description: The Zarit Burden Interview (ZBI-12) is a 12-item scale with each answer chosen from a 5-point Likert scale (Nearly always=4, Quite frequently=3, Sometimes=2, Rarely=1, Never=0). It is a shortened version of the original scale, was developed specifically for informal caregivers of PMCI/MD and covers issues such as caregiver stress and the degree to which caring is affecting their health and social life. Total score range 0 to 48 (0-10= no to mild burden, 10-20= mild to moderate burden >20= high burden).

Measure: Change on caregiver burden prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Description: The Client Service Receipt Inventory (CSRI) (32,33) scale will be used to evaluate the service utilization. This scale is an internationally used method for gathering data on service utilization and other domains relevant for economic analysis of mental health care. It has five sections: background client information, accommodation and living situation, employment history, earnings and benefits, a record of services usually used and information about informal caregiver support. The sections assessed will be consultations, admissions and visits, grouped into subsections according to hospital, specialist, primary or home care. Treatment related to hospital admissions or illness exacerbation will also be assessed. It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required.

Measure: Change on healthcare and social support services access prior to, during and after confinement.

Time: Through study completion, an average of 6 months

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Description: Use of ICTs (SmartPhone, Tablet, Computer, Smart-TV, or other) to contact healthcare and social support services, to stimulate cognition, to facilitate social connectedness (telephone call, video call, texting...), to access COVID-19 information and to enable entertainment.

Measure: Change from health, cognitive, social, informative and entertainment related uses of ICT during and after confinement.

Time: Through study completion, an average of 6 months

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Primary Outcomes

Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.

Measure: Cognitive state evaluated through Mini-Mental State Examination

Time: Pre-intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.

Measure: Change in cognitive state evaluated through Mini-Mental State Examination

Time: 6 months after the beginning of the intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.

Measure: Change in cognitive state evaluated through Mini-Mental State Examination

Time: 12 months after the beginning of the intervention

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Description: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.

Measure: Cognitive performance evaluated through Montreal Cognitive Assessment

Time: Pre-intervention

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Description: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.

Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment

Time: 6 months after the beginning of the intervention

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Description: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.

Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment

Time: 12 months after the beginning of the intervention

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Secondary Outcomes

Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.

Measure: Depressive symptoms evaluated through Geriatric Depression Scale -15

Time: Pre intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.

Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15

Time: 6 months after the beginning of the intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.

Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15

Time: 12 months after the beginning of the intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.

Measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease: score

Time: Pre-intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.

Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score

Time: 6 months after the beginning of the intervention

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Description: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.

Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score

Time: 12 months after the beginning of the intervention

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Description: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).

Measure: Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.

Time: Pre-intervention

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Description: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).

Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.

Time: 6 months after the beginning of the intervention

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Description: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).

Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living.

Time: 12 months after the beginning of the intervention

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Other Outcomes

Description: Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.

Measure: Sociodemographic data collected through a sociodemographic questionnaire

Time: Pre-intervention

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Description: Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.

Measure: Adherence to the intervention and dropouts evaluated through a session form

Time: [Pre, intra (6 months) and post intervention (12 months)]

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Primary Outcomes

Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

Measure: Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment

Time: 9 weeks

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Description: A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

Measure: Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment

Time: 12 weeks

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Description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from baseline to post-treatment assessment.

Time: 9 weeks

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Description: Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Measure: Change in score on Spatial Planning task (part of Cambridge Brain Science's online battery) from post-treatment to 3-month follow-up assessment.

Time: 12 weeks

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Description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.

Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment

Time: 9 weeks

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Description: A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.

Measure: Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment

Time: 12 weeks

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Description: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Measure: Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment

Time: 9 weeks

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Description: Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Measure: Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment

Time: 12 weeks

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Primary Outcomes

Description: Acceptability of study intervention will be qualitatively assessed at the end of week 13 via semi-structured interviews with study participants.

Measure: Acceptability of intervention assessed by semi-structured interviews

Time: Week 13

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Description: Proportion of target recruit sample achieved throughout study duration.

Measure: Recruitment rate

Time: Week 13

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Description: Proportion of participants recruited into the study who completed the intervention.

Measure: Completeness of intervention

Time: Week 13

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Description: Proportion of people recruited into the study who sustained adverse events.

Measure: Adverse event rate

Time: Week 13

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Secondary Outcomes

Description: Sedentary behaviour and physical activity time per day will be recorded using ActivPAL inclinometer.All participants will be required to wear the ActivPAL continuously for at least 7 days at baseline that will measure habitual sedentary behaviour and walking activity each day (Edwardson et al., 2017). The inclinometer will record how many minutes per day each participant is sedentary and engages in light, moderate and vigorous physical activities. A recording is made of each 60-second period (called an 'epoch'), and this is classified as being sedentary or light, moderate or vigorous physical activity. The researcher will collect data on the total minutes of sedentary behaviour per day, number of disruptions in sedentary behaviour and total time spent in physical activity (minutes per day in light, moderate and vigorous activity).

Measure: Device measured sedentary behaviour

Time: Week 1 and 13

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Description: Participants will complete a survey questionnaire about weekly time spent participating in selected sedentary behaviours such as watching television and sitting (Rosenberg et al., 2010). The options for respondents include 'None', <=15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6+ hours.

Measure: Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire

Time: Week 1 and 13

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Description: The researcher will test participant's verbal fluency (cognitive function) using the Controlled and Oral Word Association Test. The scores represent the number of correct words provided in 60 seconds. Higher scores represent better verbal fluency ability and vice versa.

Measure: Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT)

Time: Week 1 and 13

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Description: The participants will self- rate their health using five dimensions provided (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and five response levels: no problems, slight, moderate, severe, unable to/extreme problems. The EQ- Visual Analogue Scale(VAS) records the respondent's overall current health (0-100). Higher VAS scores represent best perceived health and vice versa.

Measure: Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D)

Time: Week 1 and 13

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Description: This will be evaluated using the National Adult Reading Test. Participants will be asked to read form a list of 50 words and they will be scored based on whether or not they pronounce each word correctly.

Measure: Pre-morbid intelligence

Time: Week 1 and 13

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Primary Outcomes

Description: The Oral Trail Making Test B (TMT-B) will be used to assess memory performance. It is a neuropsychological measure that provides an assessment of sequential set-shifting. Participants are asked to count from 1 to 25 switching between number and letter, eg 1-A-2-B-3-C, until stopped.

Measure: Change in memory performance

Time: Baseline,1 month

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Description: Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) will be administered to assess cognitive decline or improvement. The 12 items on the RBANS assess five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Scores can range from 0-160 and are interpreted as: 130 and above- very superior; 120-129 - superior; 110-119- high average; 90-109- average; 80-89- low average; 70-79- borderline; 60 and below extremely low.

Measure: Change in cognition

Time: Baseline, 1 month

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Description: Phonemic fluency will be assessed by asking participants to produce orally as many words as possible beginning with a specific letter or for a specific category (eg animals, fruits, etc). The test consists of three trials, of 1 min each. The higher the number of words provided, the greater the verbal fluency.

Measure: Change in phonemic fluency

Time: Baseline, 1 month

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Secondary Outcomes

Description: The 6-item version of the Lubben Social Network scale (LSNS-6) will be used to assess social isolation. For each of the 6 questions the participant rates from 0 to 5 their perceived social engagement where 0=less social engagement and 5= more social engagement. The summed total score ranges between 0 and 30. Lower total scores indicate more social isolation.

Measure: Social isolation

Time: 1 month

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Description: Loneliness will be assessed using the UCLA loneliness scale. Participants rate each item as either O ("I often feel this way"= 3),S ("I sometimes feel this way"=2), R ("I rarely feel this way"=1), N ("I never feel this way"=0). A total score is computed by adding up the response to each question and can range from 0 to 60. The average loneliness score on the measure is 20. A score of 25 or higher reflects a high level of loneliness. A score of 30 or higher reflects a very high level of loneliness.

Measure: Loneliness

Time: 1 month

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Description: The Geriatric Depression Scale (GDS) will be used to assess depression. It consists of 15 questions- 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

Measure: Depressive symptoms

Time: 1 month

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Description: An investigator developed questionnaire based on survey results published by Geldsetzer P in Annals of Internal Medicine, 3-2020 will be used to assess Covid-19 misinformation.

Measure: Misinformation about Covid-19

Time: 1 month

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Primary Outcomes

Description: Change in concentration of circulating cytokines in CSF from baseline

Measure: CSF biomarkers of pharmacodynamic response- cytokines

Time: Day 84

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Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in CSF from baseline

Measure: CSF biomarkers of pharmacodynamic response-Treg

Time: Day 84

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Description: Change in soluble TNF receptor (sTNF-R) concentration in CSF from baseline

Measure: CSF biomarkers of pharmacodynamic response-TNFR

Time: Day 84

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Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in CSF from baseline.

Measure: CSF biomarkers of AD pathology-ATN

Time: Day 84

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Description: Change in BCG on molecular markers of immune response (YKL40, and sTREM2) concentration from from Baseline.

Measure: CSF biomarkers of immune response.

Time: Day 84

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Description: Change in concentration of circulating cytokines in blood from baseline.

Measure: Blood biomarkers of pharmacodynamic response- cytokines

Time: Day 28

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Description: Change in concentration of Treg number and proportion (relative to total CD4+ and CD8+ T cells) in blood from baseline.

Measure: Blood biomarkers of pharmacodynamic response-Treg

Time: Day 28

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Description: Change in concentration of Soluble TNF receptor (sTNF-R) in blood from baseline.

Measure: Blood biomarkers of pharmacodynamic response-TNFR

Time: Day 28

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Description: Change in concentration of circulating cytokines in blood from baseline

Measure: Blood biomarkers of pharmacodynamic response- cytokines

Time: Day 84

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Description: Change in Treg number and proportion relative to total CD4+ and CD8+ T cells in blood from baseline

Measure: Blood biomarkers of pharmacodynamic response- Treg

Time: Day 84

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Description: Change in soluble TNF receptor (sTNF-R) concentration in blood from baseline

Measure: Blood biomarkers of pharmacodynamic response- TNFR

Time: Day 84

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Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.

Measure: Blood biomarkers of AD pathology

Time: Day 28

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Description: Change in concentration of ATN markers of AD pathophysiology (Amyloid-β42/40, phospho-tau, total tau and neurofilament light protein biomarkers) in blood from baseline.

Measure: Blood biomarkers of AD pathology

Time: Day 84

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Secondary Outcomes

Description: Change from baseline in Clinical Dementia Rating Sum-of-Boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)

Measure: Cognitive Measures (CDR)

Time: Day 28

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Description: Change from baseline in Clinical Dementia Rating Sum-of-boxes (CDR-SOB) score. Score range= 0-18 (0=unimpaired, 18=severe dementia)

Measure: Cognitive Measures (CDR)

Time: Day 84

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Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score.

Measure: Cognitive Measures (RBANS)

Time: Day 28

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Description: Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score

Measure: Cognitive Measures (RBANS)

Time: Day 84

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