Mild Cognitive Impairment, Alzheimer Disease
Conditions
Keywords
Alzheimer disease, cognition, transcranial direct current stimulation, exercise, mild cognitive impairment
Brief summary
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.
Detailed description
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.
Interventions
OTHERtDCS
All study participants randomized to tDCS will receive active tDCS.
OTHERExercise
Participants will exercise at TRI according to an individualized exercise prescription.
OTHERExercise Education
Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
OTHERSham tDCS
The same procedure for tDCS will be used for the sham condition, except without active current.
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The research personnel that will be administering the cognitive assessments will be blinded to treatment allocation. The patients will be blinded to stimulation type.
Intervention model description
This is a randomized, blinded, repeated-session, parallel-design study.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3) | 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
| Measure | Time frame | Description |
|---|---|---|
| n-back reaction time at study endpoint (T3) | Study endpoint (two-weeks post baseline) | A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome. |
| Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3) | 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. |
| The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3) | 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. |
| The Neuropsychiatric Inventory (NPI) at study endpoint (T3) | 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. |
Countries
Canada
Outcome results
None listed