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Report for Clinical Trial NCT03412604

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Effect of Modulating Gamma Oscillations by Transcranial Alternating Current Stimulation on Brain Structure and Function in Humans

This study aims to implement an intervention based on multiple, individualized multifocal tACS stimulation sessions based on individual PET and MRI information in patients with amyloid-positive PET with the hope that this leads to microglia activation and decrease in cerebral amyloid and tau depositions in human patients with AD.

NCT03412604 Alzheimer Disease
MeSH:Alzheimer Disease
HPO:Alzheimer disease

1 Interventions

Name: Transcranial Alternating Current Stimulation (tACS)

Description: tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
Type: Device
Group Labels: 1

tACS


Primary Outcomes

Description: Adverse Events as a result of tACS stimulation will be reported

Measure: Incidence of Treatment-Emergent Adverse Events

Time: Up to 12 weeks

Description: Changes in the amyloid load observed via PET imaging will be evaluated by comparing PET data acquired before and after the 20 tACS sessions

Measure: PET amyloid burden

Time: up to 12 weeks

Description: Changes in the tau deposition observed via PET imaging will be evaluated by comparing PET data acquired before and after the 20 tACS sessions

Measure: PET tau deposition

Time: up to 12 weeks

Secondary Outcomes

Description: Changes in the microglia activation observed via PET imaging will be evaluated by comparing PET data acquired before and after the 20 tACS sessions

Measure: PET Microglia activation

Time: up to 12 weeks

Other Outcomes

Description: Change in Adas-Cog score will be reported, to document a potential clinical benefit of tACS. The scale ranges from a total score of 0-70 with higher score indicating greater cognitive impairment.

Measure: Alzheimer's Disease Assessment Scale -Cog Score

Time: up to 12 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 rs6971

- Contraindication for undergoing MRI or receiving TMS or tACS, - >50 mSv of radiation exposure for research within the past year (PET imaging exclusion) - Presence of the Thr/Thr polymorphism in the TSPO gene (rs6971) due to low affinity binding for the PBR 28 (microlgia) PET scan - History of fainting spells of unknown or undetermined etiology that might constitute seizures.



HPO Nodes


HPO: