Mild Cognitive ImpairmentEXACTNCT03670615
Using Exercise and Electrical Brain Stimulation to Improve Memory in Dementia
A study testing tDCS, Exercise and Exercise Education in people with Mild Cognitive Impairment and Alzheimer Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- tDCS, Exercise and Exercise Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2018to 6 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- tDCS, Exercise, Exercise Education, Sham tDCS
- Keywords
- Alzheimer disease, cognition, transcranial direct current stimulation, exercise, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
All study participants randomized to tDCS will receive active tDCS.
ExerciseOther
Participants will exercise at TRI according to an individualized exercise prescription.
Exercise EducationOther
Also called Treatment as usual
Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
Sham tDCSOther
The same procedure for tDCS will be used for the sham condition, except without active current.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and tDCS | Experimental | Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention. Receives: Other: tDCS; Other: Exercise |
| Exercise Education and tDCS | Other | Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention. Receives: Other: tDCS; Other: Exercise Education |
| Exercise and Sham tDCS | Other | Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention. Receives: Other: Exercise; Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)
Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.
Measured: Study endpoint (two-weeks post baseline)
Secondary outcomes (4)
n-back reaction time at study endpoint (T3)
A measure of working memory. Reaction times in milliseconds will be recorded. Higher values represent a worse outcome.
Measured: Study endpoint (two-weeks post baseline)
Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3)
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.
Measured: Study endpoint (two-weeks post baseline)
The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3)
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.
Measured: Study endpoint (two-weeks post baseline)
The Neuropsychiatric Inventory (NPI) at study endpoint (T3)
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.
Measured: Study endpoint (two-weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start28 Nov 2018
- Primary completion1 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, blinded, repeated-session, parallel-design study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670615
- Sponsor's protocol ID
- 075-2018
- Acronym
- EXACT
- Status last verified
- May 2025
- First submitted
- 22 Aug 2018
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu CS, Herrmann N, Song BX, Ba J, Gallagher D, Oh PI, Marzolini S, Rajji TK, Charles J, Papneja P, Rapoport MJ, Andreazza AC, Vieira D, Kiss A, Lanctot KL. Exercise priming with transcranial direct current stimulation: a study protocol for a randomized, parallel-design, sham-controlled trial in mild cognitive impairment and Alzheimer's disease. BMC Geriatr. 2021 Dec 4;21(1):677. doi: 10.1186/s12877-021-02636-6.
PubMed 34863115
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
- ClinicalTrials.gov ID
- NCT03670615
- Acronym / sponsor ID
- EXACT / 075-2018
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Alzheimer disease, cognition, transcranial direct current stimulation, exercise, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, blinded, repeated-session, parallel-design study.
| Arm | Type | Receives |
|---|---|---|
| Exercise and tDCS | Experimental | Other: tDCS, Other: ExercisePatients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention. |
| Exercise Education and tDCS | Other | Other: tDCS, Other: Exercise EducationPatients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention. |
| Exercise and Sham tDCS | Other | Other: Exercise, Other: Sham tDCSPatients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAll study participants randomized to tDCS will receive active tDCS. | Other | Exercise Education and tDCS, Exercise and tDCS |
| ExerciseParticipants will exercise at TRI according to an individualized exercise prescription. | Other | Exercise and Sham tDCS, Exercise and tDCS |
| Exercise EducationAlso: Treatment as usualExercise education/ treatment as usual will include routine advice about physical activity for older adults. | Other | Exercise Education and tDCS |
| Sham tDCSThe same procedure for tDCS will be used for the sham condition, except without active current. | Other | Exercise and Sham tDCS |
Primary outcome
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.
4 secondary outcomes
n-back reaction time at study endpoint (T3)
Time frame: Study endpoint (two-weeks post baseline)
Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3)
Time frame: Study endpoint (two-weeks post baseline)
The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3)
Time frame: Study endpoint (two-weeks post baseline)
The Neuropsychiatric Inventory (NPI) at study endpoint (T3)
Time frame: Study endpoint (two-weeks post baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 34863115Liu CS, Herrmann N, Song BX, Ba J, Gallagher D, Oh PI, Marzolini S, Rajji TK, Charles J, Papneja P, Rapoport MJ, Andreazza AC, Vieira D, Kiss A, Lanctot KL. Exercise priming with transcranial direct current stimulation: a study protocol for a randomized, parallel-design, sham-controlled trial in mild cognitive impairment and Alzheimer's disease. BMC Geriatr. 2021 Dec 4;21(1):677. doi: 10.1186/s12877-021-02636-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS, Exercise and Exercise Education in people with Mild Cognitive Impairment and Alzheimer Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3) (time frame: Study endpoint (two-weeks post baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.