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OpenTrials
Completed

NCT Number: NCT03670615

Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia

Mild cognitive impairment and Alzheimer's disease are conditions that involve memory difficulties. Transcranial direct current stimulation is a type of brain stimulation. It may help improve these memory difficulties. However, it works better on active brain areas. This study looks at if combining exercise and applying current to important parts of the brain can help improve memory in people with Mild Cognitive Impairment or Alzheimer's disease.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M3H0A7, Canada

About this study

Objectives: To assess the efficacy of a combined exercise and tDCS treatment for improving cognitive outcomes in mild cognitive impairment and mild Alzheimer's disease.

Study Design: Eligible participants will be randomized to one of three interventions: Exercise and tDCS, Treatment as usual (TAU/exercise education) and tDCS, or Exercise and sham tDCS. Participants randomized to an exercise group will undergo exercise, followed by either sham or active tDCS. Participants randomized to TAU will receive written information in accordance with the Canadian Physical Activity Guidelines for older adults and tDCS for the same duration. Cognition, neuropsychiatric symptoms and blood samples for biomarker analysis will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females ≥50 years of age
  • DSM-5 criteria for major or mild neurocognitive disorder due to AD or mixed AD/vascular disease
  • Mild severity of impairment (standardized Mini-Mental State Examination (MMSE) score ≥19)
  • Read and communicate in English

Exclusion criteria

  • Change in cognitive enhancing medications (ChEIs and/or memantine) less than 3 months prior to study screen
  • Change in anticonvulsants or psychotropic medications less than 1 month prior to study screen
  • Currently taking benzodiazepines
  • Presence of metal implants that would preclude safe use of tDCS (e.g. pace-maker)
  • Significant neurological condition (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
  • Current psychiatric disorders (e.g. schizophrenia, bipolar disorder, depression, psychosis) or current substance use disorder
  • Medical contraindications to increasing activity level according to the Canadian Society of Exercise Physiology Questionnaire

Treatment and study plan

tDCS

Other

All study participants randomized to tDCS will receive active tDCS.

Exercise

Other

Participants will exercise at TRI according to an individualized exercise prescription.

Exercise Education

Other

Exercise education/ treatment as usual will include routine advice about physical activity for older adults.

Other names: Treatment as usual

Sham tDCS

Other

The same procedure for tDCS will be used for the sham condition, except without active current.

Primary outcomes

  1. Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)

    Time frame: Study endpoint (two-weeks post baseline)

    Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.

Secondary outcomes

  1. n-back reaction time at study endpoint (T3)

    Time frame: Study endpoint (two-weeks post baseline)

    A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.

  2. Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3)

    Time frame: Study endpoint (two-weeks post baseline)

    Assesses recall memory. Number of words not recalled will be tallied. Word recall scores range from 0 to 10. Higher scores represent a worse outcome.

  3. The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3)

    Time frame: Study endpoint (two-weeks post baseline)

    A brief measure of global cognition that includes assessments of orientation, short-term total memory, executive function, language abilities, attention and visuospatial ability. MoCA scores range from 0 to 30. Higher scores represent a better outcome.

  4. The Neuropsychiatric Inventory (NPI) at study endpoint (T3)

    Time frame: Study endpoint (two-weeks post baseline)

    A widely used assessment of behavior disturbances in dementia including: apathy, agitation, delusions, hallucinations, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, and eating. Frequency and severity of each symptom is measured using subscales. Frequency and severity are judged using a 4-point scale (ranging from 1-4) and 3-point scale (ranging from 1-3) respectively. A 6-point scale for each symptom is used to evaluate caregiver distress (ranging from 0-5). Higher values represent a worse outcome.

Other outcomes

  1. Concentration of blood biomarkers of brain plasticity at study endpoint (T3)

    Time frame: Study endpoint (two-weeks post baseline)

    Biomarkers associated with exercise, tDCS outcomes, angiogenesis and neurogenesis will be obtained from blood work and analyzed using enzyme linked immunosorbent assays.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition

Acronym: EXACT

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2018
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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