← Back to Search

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

Must not have

Current use of benzodiazepines

Presence of significant neurological conditions (e.g. epilepsy, Parkinson's disease, multiple sclerosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over 2 weeks baseline to endpoint

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking benzodiazepines.

Select...

I have a significant neurological condition like epilepsy or Parkinson's.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over 2 weeks baseline to endpoint for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)

Secondary study objectives

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 more

Other study objectives

Changes in concentration of blood biomarkers of brain plasticity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met