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Exercise + tDCS for Alzheimer's Disease (EXACT Trial)
N/A
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meeting DSM-5 criteria for major or mild neurocognitive disorder due to AD or mixed AD/vascular disease
Males or females ≥50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change over 2 weeks baseline to endpoint
Awards & highlights
EXACT Trial Summary
This trial looks at whether combining exercise with transcranial direct current stimulation, a type of brain stimulation, can help improve memory in people with mild cognitive impairment or Alzheimer's disease.
Who is the study for?
This trial is for individuals over 50 with mild Alzheimer's or cognitive impairment who can communicate in English and have an MMSE score of at least 19. It's not suitable for those recently changing medication, using benzodiazepines, having metal implants like pacemakers, other significant neurological conditions, psychiatric disorders, substance use disorder, or medical reasons preventing exercise.Check my eligibility
What is being tested?
The study tests if brain stimulation (tDCS) combined with exercise improves memory in people with Mild Cognitive Impairment or Alzheimer's. Participants will receive either real tDCS while exercising or a sham treatment without active stimulation alongside exercise education.See study design
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the electrode site on the head, itching, tingling during the procedure and headache. Exercise might cause typical physical exertion-related issues such as muscle soreness.
EXACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alzheimer's or a mix of Alzheimer's and vascular cognitive impairment.
Select...
I am 50 years old or older.
EXACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change over 2 weeks baseline to endpoint
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change over 2 weeks baseline to endpoint
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)
Secondary outcome measures
Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)
Change in cognition: n-back reaction time
Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores
+1 moreOther outcome measures
Changes in concentration of blood biomarkers of brain plasticity
EXACT Trial Design
3Treatment groups
Experimental Treatment
Group I: Exercise and tDCSExperimental Treatment2 Interventions
Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.
Group II: Exercise and Sham tDCSExperimental Treatment2 Interventions
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Group III: Exercise Education and tDCSExperimental Treatment2 Interventions
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,237 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't changed my dementia medication in the last 3 months.I am currently taking benzodiazepines.I haven't changed my seizure or mood medications in the last month.I have been diagnosed with Alzheimer's or a mix of Alzheimer's and vascular cognitive impairment.I am 50 years old or older.I have a significant neurological condition like epilepsy or Parkinson's.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise and tDCS
- Group 2: Exercise Education and tDCS
- Group 3: Exercise and Sham tDCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining openings for participants in this research?
"Clinicaltrials.gov indicates that this trial, first posted on November 28th 2018 and recently updated February 25th 2022, is actively enrolling participants."
Answered by AI
How many participants are accepted into this research project?
"Affirmative. The clinicaltrials.gov platform reveals that this research is currently accepting participants, which originated on November 28th 2018 and was last modified on February 25th 2022. 60 people need to be recruited from one medical site."
Answered by AI
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