Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia

Alzheimer Disease Clinical Trial

— EXACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670615
• Other study ID #: 075-2018
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Mehreen Siddiqui
• Phone: 416-480-6100
• Email: mehreen.siddiqui[@]sri.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• tDCS
All study participants randomized to tDCS will receive active tDCS.
• Exercise
Participants will exercise at TRI according to an individualized exercise prescription.
• Exercise Education
Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
• Sham tDCS
The same procedure for tDCS will be used for the sham condition, except without active current.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in concentration of blood biomarkers of brain plasticity	Biomarkers associated with exercise, tDCS outcomes, angiogenesis and neurogenesis will be obtained from blood work and analyzed using enzyme linked immunosorbent assays.	Change over 2 weeks (Baseline to Endpoint)
Primary	Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)	Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.	Change over 2 weeks (Baseline to Endpoint)
Secondary	Change in cognition: n-back reaction time	A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.	Change over 2 weeks (Baseline to Endpoint)
Secondary	Change in cognition: The Word Recall Task from the Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog)	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.	Change over 2 weeks (Baseline to Endpoint)
Secondary	Change in global cognitive function: The Montreal Cognitive Assessment (MoCA) Total Scores	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.	Change over 2 weeks Baseline to Endpoint
Secondary	Change in neuropsychiatric symptoms: The Neuropsychiatric Inventory (NPI)	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.	Change over 2 weeks (Baseline to Endpoint)