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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05508841
• Other study ID #: #22-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: Baycrest
• Contact: Carlos Roncero, PhD
• Email: troncero[@]research.baycrest.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• tDCS and Cognitive Training
Participants will receive mild stimulation or no stimulation along with cognitive training

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Baycrest	BrightFocus Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-Back	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	3 months