Mild Cognitive ImpairmentNCT02959502
Home-Based CR and tDCS to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
A study testing Receive tDCS+CR and Facilitate tDCS + CR in people with Mild Cognitive Impairment and Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's Dementia
- What is being tested?
- Receive tDCS+CR and Facilitate tDCS + CR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 (on day of randomization)
- DSM-IV criteria for Mild Neurocognitive Disorder ("MCI")
- Willingness to provide informed consent
- MADRS score of 10 or below
- Availability of a study partner who has regular contact with the participant
- Ability to read and communicate in English (with corrected vision and hearing, if needed)
Show all 17Show fewer
- Age ≥ 60 (on day of randomization)
- Meets DSM-IV criteria for one or more MDE(s)with:
- an offset of 2 months to 5 years from the screening visit date. It is not necessary for this (these) episode(s) to have received medical attention
- OR
- an offset of 5 years or more from the screening visit date. It is necessary that at least one MDE received medical attention (e.g., previously been on one or more antidepressant(s), saw a psychiatrist, primary care physician, or had a previous hospitalization). Also, the MDE must have occurred during the participant's adult life (i.e., at 18 years of age or older).
- MADRS score of 10 or below
- Willingness to provide informed consent
- Availability of a study partner who has regular contact with the participant
- Ability to read and communicate in English (with corrected vision and hearing, if needed)
- Willingness to provide informed consent
- Ability to read and communicate in English (with corrected vision and hearing, if needed)
Who cannot join
- Met DSM-IV criteria for Major Depressive Episode in past 10 years
- Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
- DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months
- High risk for suicide
- Significant neurological condition (e.g., stroke, seizure disorder, MS)
- Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension)
Show all 21Show fewer
- Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks
- Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. The following psychotropic medications are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry: zopiclone, trazadone, or a benzodiazepine; gabapentin, pregabalin, duloxetine, venlafaxine, or low-dose tricyclic antidepressants if prescribed for chronic pain.
- A pace-maker or other metal implants that would preclude safe use of tDCS.
- MDD Group
- Meets DSM-IV criteria for Major Neurocognitive Disorder ("dementia")
- Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
- DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months.
- High risk for suicide.
- Significant neurological condition (e.g., stroke, seizure disorder, MS)
- Unstable medical illness (e.g., uncontrolled diabetes mellitus or hypertension)
- Participants taking anticonvulsants, and other psychotropic medication (see exception below) that cannot be safely tapered and discontinued. In addition to any antidepressant, the following psychotropic medications are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry: zopiclone, trazodone, or a benzodiazepine; and gabapentin or pregabalin if prescribed for chronic pain.
- Having taken a cognitive enhancer (acetylcholinesterase inhibitor or memantine) within the past 6 weeks.
- A pace-maker or other metal implants that would preclude safe use of tDCS.
- Facilitator Group
- Physical or medical illness that prevents participant from learning or administering CR + tDCS, as determined by the research team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-Based Cognitive Remediation and Transcranial Direct Current Stimulation to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.
Read the detailed description
By the time Alzheimer's Dementia (AD) and related disorders are diagnosed, the brain has sustained substantial insult that limits the efficacy of current treatments. Preventive interventions are urgently needed but the majority of prevention studies require large numbers of participants, long follow-up periods, and frequent study visits. It is not feasible for many geriatric patients to attend clinics for treatment on a daily basis due to mobility and transportation restrictions, associated costs, and lack of rural clinic locations. Interventions delivered remotely, or administered within an individual's home, allow for preventative treatments to be made accessible to a wider range of individuals. Thus, the overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD. These high-risk individuals that will be targeted in this proposal are: (1) older adults with Mild Cognitive Impairment (MCI), (2) older adults with Major Depressive Disorder (MDD), and (3) older adults with MCI and MDD.
The proposed intervention combines cognitive remediation (CR) and non-invasive brain stimulation - transcranial Direct Current Stimulation (tDCS), to be delivered in the participants' home environment. Twenty couples (40 participants) will be recruited, with one member defined as the "patient" and the second member defined as the "caregiver" to the patient. These caregivers will facilitate the delivery of the study intervention (i.e., CR+tDCS). Participants with a diagnosis of MCI or MDD or both, who have a caregiver, will receive open-label, active CR+tDCS over a period of 8 weeks. Both CR and tDCS have been shown to induce neuroplasticity and improve cognition. The aim of this pilot study is to assess the feasibility of delivering these combined interventions at home.
- Conditions
- Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's Dementia, Transcranial Direct Current Stimulation, tDCS
- Being tested
- Receive tDCS+CR, Facilitate tDCS + CR
- Medical subject headings
- Cognitive Dysfunction, Depressive Disorder, Major, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive tDCS+CROther
Also called transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)
Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time.
Facilitate tDCS + CROther
Also called transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)
Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will be trained to deliver tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory.
| Study group | Role | What they receive |
|---|---|---|
| Receive tDCS + CR | Experimental | Receive tDCS+CR: Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time. Receives: Other: Receive tDCS+CR |
| Facilitate tDCS + CR | Experimental | Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will trained to deliver tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Receives: Other: Facilitate tDCS + CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of training a facilitator (caregiver) to facilitate the administration of CR+tDCS to their "patient" partner as indicated by a positive response in the Perceived Competence Scale at 24 months from study baseline.
Measured: Approximately 24 months after baseline
Fidelity to delivering home-based CR+tDCS by a facilitator (caregiver) to the participant as indicated by the compliance rate during the induction phase and boosters.
Compliance rate is defined as the the number of sessions completed as assessed by the Session Log divided by the total number of sessions across the induction phase and boosters.
Measured: Baseline and approximately 24 months after baseline
Secondary outcomes (4)
Assess change in Quality of Life Scale scores among patients between baseline and at the end of the 8-week course.
Measured: Baseline and 8 weeks after baseline.
Measure the change in Quality of Life Scale scores among facilitators between baseline and at the end of the 8-week course.
Measured: Baseline to 8 weeks after baseline.
Measure the change in cognition (as indicated by a change in the Screen for Cognitive Impairment in Psychiatry) among patients between baseline and at the end of the 8-week course
Measured: Baseline to 8 weeks after baseline.
Measure the change in cognition (as indicated by a change in the Screen for Cognitive Impairment in Psychiatry) among facilitators between baseline and at the end of the 8-week course
Measured: Baseline to 8 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start31 Oct 2016
- Primary completion23 Mar 2023
- Study completionDec 2026 (estimated)
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.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- CAMH Foundation
- Responsible party
- Principal investigator, Tarek Rajji, Centre for Addiction and Mental Health
- Investigators
- Tarek Rajji, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959502
- Sponsor's protocol ID
- 069/2016
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2016
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Genadry F, Kalyani P, Elgallab BM, Brooks H, Blumberger DM, Kumar S, Mulsant BH, Bowie CR, Rajji TK. Home-based cognitive remediation and transcranial direct current stimulation to enhance cognition in older adults with major depressive disorder or mild cognitive impairment: An open label study. Int Psychogeriatr. 2026 Mar;38(2):100116. doi: 10.1016/j.inpsyc.2025.100116. Epub 2025 Jul 24.
PubMed 40713415
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Cognitive Remediation and Transcranial Direct Current Stimulation to Enhance Cognition in Persons With Mild Cognitive Impairment and Late Life Depression
- ClinicalTrials.gov ID
- NCT02959502
- Acronym / sponsor ID
- 069/2016
- Conditions
- Mild Cognitive Impairment, Major Depressive Disorder, Alzheimer's Dementia, Transcranial Direct Current Stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- CAMH Foundation
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.
Detailed description
By the time Alzheimer's Dementia (AD) and related disorders are diagnosed, the brain has sustained substantial insult that limits the efficacy of current treatments. Preventive interventions are urgently needed but the majority of prevention studies require large numbers of participants, long follow-up periods, and frequent study visits. It is not feasible for many geriatric patients to attend clinics for treatment on a daily basis due to mobility and transportation restrictions, associated costs, and lack of rural clinic locations. Interventions delivered remotely, or administered within an individual's home, allow for preventative treatments to be made accessible to a wider range of individuals. Thus, the overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD. These high-risk individuals that will be targeted in this proposal are: (1) older adults with Mild Cognitive Impairment (MCI), (2) older adults with Major Depressive Disorder (MDD), and (3) older adults with MCI and MDD.
The proposed intervention combines cognitive remediation (CR) and non-invasive brain stimulation - transcranial Direct Current Stimulation (tDCS), to be delivered in the participants' home environment. Twenty couples (40 participants) will be recruited, with one member defined as the "patient" and the second member defined as the "caregiver" to the patient. These caregivers will facilitate the delivery of the study intervention (i.e., CR+tDCS). Participants with a diagnosis of MCI or MDD or both, who have a caregiver, will receive open-label, active CR+tDCS over a period of 8 weeks. Both CR and tDCS have been shown to induce neuroplasticity and improve cognition. The aim of this pilot study is to assess the feasibility of delivering these combined interventions at home.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive tDCS + CR | Experimental | Other: Receive tDCS+CRReceive tDCS+CR: Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time. |
| Facilitate tDCS + CR | Experimental | Other: Facilitate tDCS + CROver the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will trained to deliver tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age > 60 (on day of randomization)
- DSM-IV criteria for Mild Neurocognitive Disorder ("MCI")
- Willingness to provide informed consent
- MADRS score of 10 or below
- Availability of a study partner who has regular contact with the participant
Key exclusion criteria (21 listed)
- Met DSM-IV criteria for Major Depressive Episode in past 10 years
- Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or OCD
- DSM-IV diagnosis of alcohol or other substances use disorder within the past 12 months
- High risk for suicide
- Significant neurological condition (e.g., stroke, seizure disorder, MS)
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 |
|---|---|---|
| Receive tDCS+CRAlso: transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time. | Other | Receive tDCS + CR |
| Facilitate tDCS + CRAlso: transcranial Direct Current Stimulation (tDCS), Cognitive Remediation (CR)Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will be trained to deliver tDCS \&CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. | Other | Facilitate tDCS + CR |
Primary outcome
Feasibility of training a facilitator (caregiver) to facilitate the administration of CR+tDCS to their "patient" partner as indicated by a positive response in the Perceived Competence Scale at 24 months from study baseline.
Time frame: Approximately 24 months after baseline
Fidelity to delivering home-based CR+tDCS by a facilitator (caregiver) to the participant as indicated by the compliance rate during the induction phase and boosters.
Time frame: Baseline and approximately 24 months after baseline
Compliance rate is defined as the the number of sessions completed as assessed by the Session Log divided by the total number of sessions across the induction phase and boosters.
4 secondary outcomes
Assess change in Quality of Life Scale scores among patients between baseline and at the end of the 8-week course.
Time frame: Baseline and 8 weeks after baseline.
Measure the change in Quality of Life Scale scores among facilitators between baseline and at the end of the 8-week course.
Time frame: Baseline to 8 weeks after baseline.
Measure the change in cognition (as indicated by a change in the Screen for Cognitive Impairment in Psychiatry) among patients between baseline and at the end of the 8-week course
Time frame: Baseline to 8 weeks after baseline.
Measure the change in cognition (as indicated by a change in the Screen for Cognitive Impairment in Psychiatry) among facilitators between baseline and at the end of the 8-week course
Time frame: Baseline to 8 weeks after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 40713415Genadry F, Kalyani P, Elgallab BM, Brooks H, Blumberger DM, Kumar S, Mulsant BH, Bowie CR, Rajji TK. Home-based cognitive remediation and transcranial direct current stimulation to enhance cognition in older adults with major depressive disorder or mild cognitive impairment: An open label study. Int Psychogeriatr. 2026 Mar;38(2):100116. doi: 10.1016/j.inpsyc.2025.100116. Epub 2025 Jul 24.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tarek Rajji, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive tDCS+CR and Facilitate tDCS + CR in people with Mild Cognitive Impairment and Major Depressive Disorder, run by Centre for Addiction and Mental Health 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 17 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of training a facilitator (caregiver) to facilitate the administration of CR+tDCS to their "patient" partner as indicated by a positive response in the Perceived Competence Scale at 24 months from study baseline. (time frame: Approximately 24 months after baseline). The study lists 2 primary outcomes in all. 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 NCT02959502, 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 13 Apr 2026.