Clincosm LogoSign in Get a demo

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

Sponsor
Baycrest (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05508841
Collaborator
BrightFocus Foundation (Other)
42
Enrollment
1
Location
3
Arms
52
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: tDCS and Cognitive Training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 4mA Stimulation

Other: tDCS and Cognitive Training
Participants will receive mild stimulation or no stimulation along with cognitive training
Active Comparator: 2mA Stimulation

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baycrest Health Sciences Toronto Ontario Canada M6A 2E1

Sponsors and Collaborators

  • Baycrest
  • BrightFocus Foundation

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Tyler Roncero, Principal Investigator, Baycrest
ClinicalTrials.gov Identifier:
NCT05508841
Other Study ID Numbers:
  • #22-18
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Aug 23, 2022