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

Primary Purpose

Alzheimer Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
tDCS and Cognitive Training
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baycrest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

4mA Stimulation

2mA Stimulation

SHAM

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 18, 2022
Last Updated
August 19, 2022
Sponsor
Baycrest
Collaborators
BrightFocus Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05508841
Brief Title
Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation
Official Title
Understanding How Alzheimer's Disease Impacts the Therapeutic Response to Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
BrightFocus Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4mA Stimulation
Arm Type
Experimental
Arm Title
2mA Stimulation
Arm Type
Active Comparator
Arm Title
SHAM
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
tDCS and Cognitive Training
Intervention Description
Participants will receive mild stimulation or no stimulation along with cognitive training
Primary Outcome Measure Information:
Title
N-Back
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Roncero, PhD
Email
troncero@research.baycrest.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yashna Kochar, H BSc
Email
ykochar@research.baycrest.org
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Roncero, PhD
Phone
416-725-2500
Ext
2522
Email
troncero@research.baycrest.org
First Name & Middle Initial & Last Name & Degree
Yashna Kochar, H. BSc
Phone
416-785-2500
Ext
2522
Email
ykochar@research.baycrest.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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