Prevention of Alzheimer's Disease With CR Plus tDCS in Mild Cognitive Impairment and Depression (PACt-MD) (PACt-MD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02386670 |
Recruitment Status :
Active, not recruiting
First Posted : March 12, 2015
Last Update Posted : April 22, 2021
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | February 27, 2015 | ||||
First Posted Date ICMJE | March 12, 2015 | ||||
Last Update Posted Date | April 22, 2021 | ||||
Actual Study Start Date ICMJE | January 2015 | ||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in cognitive scores over time [ Time Frame: Approximately 4, 12, 24, 36, 48, 60 months after baseline ] Z-scores for 18 measures of 12 selected cognitive tests will be calculated based on an healthy comparison group; based on these measures, in turn, z-scores will be averaged into six z-scores for six cognitive domains (executive functioning, language, speed of processing, verbal memory, visual memory, and working memory); finally, the six domain z-scores will be averaged into a composite cognitive score, the change of which is the study primary outcome measure that will be used for H1 and H3.
|
||||
Original Primary Outcome Measures ICMJE |
Change in cognitive scores over time [ Time Frame: Approximately 4, 12, 24, 36, 48, 60 months after baseline ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Percentage of subjects who remain free of MCI or dementia over time [ Time Frame: Approximately 4, 12, 24, 36, 48, 60 months after baseline ] Based on consensus conference diagnosis made according to DSM-5
|
||||
Original Secondary Outcome Measures ICMJE |
Percentage of subjects who remain free of MCI or dementia over time [ Time Frame: Approximately 4, 12, 24, 36, 48, 60 months after baseline ] | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Prevention of Alzheimer's Disease With CR Plus tDCS in Mild Cognitive Impairment and Depression (PACt-MD) | ||||
Official Title ICMJE | Prevention of Alzheimer's Dimentia With Cognitive Remediation Plus Transcranial Direct Current Stimulation in Mild Cognitive Impairment and Depression | ||||
Brief Summary | This 7-year randomized controlled trial will compare the efficacy of non-invasive brain stimulation (trans-cranial Direct Current Stimulation - tDCS) combined with cognitive remediation (CR) versus sham ("placebo") tDCS combined with sham ("placebo") CR in slowing down cognitive decline and preventing Alzheimer's Dementia in older persons with mild cognitive impairment or major depressive disorder with or without mild cognitive impairment. | ||||
Detailed Description | By the time Alzheimer's Dementia (AD) and related disorders (ADRD) are diagnosed the brain has sustained substantial insult that limits the efficacy of current treatments. Preventive interventions are urgently needed but prevention studies require large numbers of participants and long follow-up periods unless they can target a high-risk population. The investigators propose to study the efficacy of a preventive intervention for AD in three high risk groups: (1) older persons with Mild Cognitive Impairment (MCI); (2) older persons with a major depressive disorder (MDD) without MCI; and (3) older persons with MDD and MCI. MCI is considered a prodromal condition for dementia with a progression rate of about 1% per month. MDD has independently been identified as one of the most promising targets for AD prevention studies since, even after successful treatment of their depressive episode, older persons with remitted MDD develop MCI or dementia at a rate of 1-2% per month. The investigators proposed intervention is a combination of cognitive remediation (CR) and non-invasive brain stimulation - transcranial Direct Current Stimulation (tDCS). Participants with MCI or MDD (with or without MCI) will be randomized to tDCS + CR or sham ("palcebo") tDCS + sham ("placebo") CR. Both CR and tDCS have been shown to induce neuroplasticity and improve cognition. The investigators hypothesize that their combination will enhance cognitive reserve and protect against cognitive decline and the onset of MCI in those with "normal" cognition or AD in those with MCI. The investigators design is informed by their experience conducting randomized controlled trials (RCTs) in older participants with dementia, MCI, or MDD over more than two decades. In the investigators recent donepezil prevention trial, combining donepezil with standard antidepressant maintenance prevented cognitive decline and the incidence of dementia in participants who had had both MDD and MCI. Building on this prevention trial, the investigators conceptualize the proposed study as a high-risk, high-gain RCT aimed at enhancing cognitive reserve and preventing cognitive decline and dementia in a high risk population. If the investigators are successful in this high risk population, then tDCS + CR can be tested in, and extended to, the general population (i.e., for universal prevention) or other groups at high risk for AD (i.e., for selective or indicated prevention). Five Toronto academic sites with a history of successful collaboration will consent up to a total of 500 participants meeting criteria for MCI (age 60 and older) or MDD (age 65 and older) to reach a target of 375 enrolled participants initiating the study intervention. Participants will be randomized to either: i) tDCS + CR or ii) sham tDCS + sham CR. They will first receive tDCS + CR (or sham + sham) 5 days a week for 8 weeks, followed by home-based CR (or sham) and booster sessions of tDCS + CR (or sham + sham) for 5 days every 6 months until they develop dementia (or MCI for those who are deemed cognitively intact at baseline) or complete the study. During the COVID-19 pandemic, the study has been modified to be administered in a hybrid manner to accommodate both in-person and virtual assessments. Clinical and cognitive assessments (every 12 months) can be done in person or remotely (via telephone or using WebEx/Zoom). Some assessments are modified to accommodate the change in format of administration while maintaining the validity and integrity of the data. The assessments that cannot be done via phone or videoconference will temporarily not be done. Similarly, the intervention booster group sessions (every 6 months) can also be provided in two formats of in-person or virtual (via WebEx or Zoom) sessions. The tDCS administration cannot be done remotely and hence the virtual booster sessions will only consist of the CR exercises. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
375 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2022 | ||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | MCI Group Inclusion:
Exclusion:
MDD Group Inclusion:
Exclusion:
Control group Inclusion:
Exclusion:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02386670 | ||||
Other Study ID Numbers ICMJE | 041-2014 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Benoit Mulsant, Centre for Addiction and Mental Health | ||||
Original Responsible Party | Benoit Mulsant, Centre for Addiction and Mental Health, Physician-in-Chief | ||||
Current Study Sponsor ICMJE | Centre for Addiction and Mental Health | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
PRS Account | Centre for Addiction and Mental Health | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |