Covid 19 Research using Clinical Trials (Home Page)
Report for D010300: Parkinson Disease NIH
(Synonyms: Parki, Parkin, Parkins, Parkinson, Parkinson Di, Parkinson Dis, Parkinson Dise, Parkinson Diseas, Parkinson Disease, Parkinsonian)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug704 | DNL151 Wiki | 0.58 |
| drug1980 | Questionnaire and interview Wiki | 0.58 |
| drug2641 | Video Dance classes Wiki | 0.58 |
| drug2602 | Unsupervised physical activities Wiki | 0.58 |
| drug1822 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
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There are 3 clinical trials
Clinical Trials
1 A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL151 in subjects with Parkinson's disease.
NCT04056689 Parkinson's Disease Drug: DNL151 Drug: Placebo MeSH:Parkinson Disease
Primary Outcomes
Measure: Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: Randomization to Day 42Measure: Number of Subjects with laboratory test abnormalities Time: Randomization to Day 42
Measure: Number of Subjects with vital sign abnormalities Time: Randomization to Day 42
Measure: Number of Subjects with electrocardiogram (ECG) abnormalities Time: Randomization to Day 42
Measure: Number of Subjects with clinically significant neurological examination abnormalities Time: Randomization to Day 42
Secondary Outcomes
Measure: Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151 Time: Randomization to Day 28Measure: Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151 Time: Randomization to Day 28
Measure: Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151 Time: Randomization to Day 28
Measure: Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151 Time: Randomization to Day 28
Measure: Pharmacokinetic measure of CSF concentrations of DNL151 Time: Randomization to Day 28
Measure: Pharmacodynamic measure of pS935 in whole blood Time: Randomization to Day 28
Measure: Pharmacodynamic measure of pRab10 in PBMCs Time: Randomization to Day 28
2 The Impact of Video Dance Class and Unsupervised Physical Activity on Parkinson's People During the Covid-19 Pandemic: Interventional
The aim of this study is to analyze the impact of video dance class and unsupervised physical activity on clinical-functional parameters, self-isolation and non-motors symptoms in people with Parkinson's disease during the Covid-19 pandemic.
NCT04422353 Parkinson Disease Parkinson Disease 10 Other: Video Dance classes Other: Unsupervised physical activities MeSH:Parkinson Disease
Primary Outcomes
Description: The quality of life (QoL) will be measured by the Parkinson's Disease Quality of life (PDQ-8). PDQ-8 is a reduced version of a specific health status questionnaire comprising 39 items, with 8 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Each item is grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems).
Measure: Quality of life (QoL) Time: Change from baseline at 12 weeks.Description: This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no about how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.
Measure: Depressive symptoms - Geriatric Depression Scale - 15 item Time: Change from baseline at 12 weeks.Description: This outcome will be measure for the International Physical Activity Questionnaires (IPAQ). The IPAQ comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
Measure: Physical Activity - International Physical Activity Questionnaires (IPAQ) Time: Change from baseline at 12 weeks.Secondary Outcomes
Description: Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment. This evaluation accesses different cognitive domains and investigates the individual's abilities in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation, and orientation. The total score of the MoCA is 30 points, with a score of 26, or more, considered normal and less than 26 is considered a cognitive impairment.
Measure: Cognitive function - Montreal Cognitive Assessment by telephone Time: Change from baseline at 12 weeks.Description: This outcome will be measure for the Falls - Falls Efficacy Scale - International (FES-I). FES-I can be administered as self-completion questionnaires, or administered verbally as part of a research interview or clinical assessment. To calculate the FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges as follows: minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).
Measure: Falls - Falls Efficacy Scale - International Time: Change from baseline at 12 weeks.Description: The Five Times Sit to Stand Test measures one aspect of transfer skill. This test quantifies functional lower extremity strength and identifies movement strategies a people use to complete the transitional movement.
Measure: Functional lower extremity strength -Five Times Sit to Stand Test Time: Change from baseline at 12 weeks.3 Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients
The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease. These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.
NCT04466839 Parkinson Disease COVID Other: Questionnaire and interview MeSH:Parkinson Disease
Primary Outcomes
Description: To compare quality of life using Parkinson Disease Questionnaire-8 Items (PDQ-8 ), during the period of confinement linked to the Covid-19 pandemic and 6 months after the end of the pandemic in patients with idiopathic Parkinson's disease. The minimum value is "never" and maximum value is "always"
Measure: Impact of containment related to the Covid-19 pandemic. Time: 6 months after the end of the pandemicSecondary Outcomes
Description: Describe in a cohort of Parkinson's patients the conditions of confinement during the confinement period linked to the Covid-19 pandemic such as lifestyle (patient living alone, patient living with a caregiver, patient living in nursing home) and continuing paramedical care (physiotherapist, speech therapist), thanks to a psychosocial assessment
Measure: Conditions of containment during the Covid-19 pandemic. Time: Day 1Description: Infected patients will be defined as having had a positive polymerase chain reaction (PCR) or compatible chest scanner. Patients potentially infected: patients who presented symptoms during the period which could suggest an infection by the Covid-19 virus: cough, fever and dyspnea
Measure: The number of patients infected or possibly infected with Covid-19 Time: 6 months after the end of the pandemicDescription: Patients will be asked to list the 3 main symptoms that have changed during the confinement period
Measure: Symptoms modifications Time: 6 months after the end of the pandemic