Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation

Not Applicable

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Other: tDCS and Cognitive Training

• Registration Number: NCT05508841
• Lead Sponsor: Baycrest

Brief Summary

There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Study Start: 2022-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Mild to Moderate AD
• Score between 18 and 25 on the MoCA
• Able to do the N-Back task during the initial screening

Exclusion Criteria

• No history of stroke or TBI
• No shunts or metal in the body
• No history of significant heart disease, alcoholism and drug use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SHAM	tDCS and Cognitive Training	-
4mA Stimulation	tDCS and Cognitive Training	-
2mA Stimulation	tDCS and Cognitive Training	-

Primary Outcome Measures

Name	Time	Method
N-Back	3 months	The primary outcome measure will be change on an N-Back Task, both a trained version and an untrained version. This change will be measured in terms of the average response time

Trial Locations

Locations (1)

Baycrest Health Sciences; 🇨🇦 Toronto, Ontario, Canada