Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03402919|
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : October 4, 2019
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|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||2300 participants|
|Official Title:||The Comprehensive Assessment of Neurodegeneration and Dementia Study|
|Actual Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Normal healthy elderly
participants with no subjective or objective cognitive deficits or decline.
Subjective Cognitive Decline
Participants with a complaint of subjective cognitive impairment, but no objective evidence of such.
Mild Cognitive Impairment (MCI)
Participants with objective evidence of cognitive impairment, but it does not impact on daily function.
Participants meeting criteria of MCI who also show signs of cerebrovascular disease on imaging but have no history of stroke.
Participants with dementia of the Alzheimer's type according to the National Institute of Aging-Alzheimer's Association criteria
Dementia of Mixed Etiology
Participants with dementia and evidence of more than one etiology.
Lewy Body/Parkinson's spectrum
Participants with Parkinson's disease who show mild or moderate cognitive impairment and/or dementia.
Frontotemporal dementia (FTD) spectrum
Participants with behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, or corticobasal syndrome
- Montreal Cognitive Assessment (MoCA) score [ Time Frame: 2 years ]change in MoCA total score. The MoCA is a test of global cognition scored out of 30 with a higher score indicating better performance. The minimum score is 0 and the maximum score is 30.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
2300 English and/or French-speaking participants recruited from across Canada in the following groups:
- 650 Cognitively healthy volunteers
- 300 volunteers with Subjective Cognitive Decline
- 400 volunteers with Mild Cognitive Impairment
- 200 volunteers with Vascular Mild Cognitive Impairment
- 150 volunteers with Alzheimer's disease
- 200 volunteers with Dementia of Mixed Etiology
- 200 volunteers with Parkinson's disease and cognitive impairment
- 200 volunteers with Frontotemporal spectrum dementia
- Has subjective or objective cognitive impairment
- Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from a caregiver/family member)
- Sufficient proficiency in English or French to undertake self report and neuropsychological testing
- Geographic accessibility to the study site
- Must have a study partner who can participate as required in the protocol (provide corroborative information)
- The presence of other significant known chronic brain disease such as: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, malignant tumors, Parkinson's disease (other than for the Parkinson's/Lewy Body Dementia cohort), and other rarer brain illnesses
- Ongoing alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures
- Symptomatic stroke within the previous year
- MoCA < 13
- Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402919
|Contact: Howard Chertkow, MD||514 340 8222 ext firstname.lastname@example.org|
|Contact: Victor Whitehead, MSW||514 340 8222 ext email@example.com|
|Study Director:||Michael Borrie, MD||Western University|
Documents provided by McGill University:
|Responsible Party:||McGill University|
|Other Study ID Numbers:||
|First Posted:||January 18, 2018 Key Record Dates|
|Last Update Posted:||October 4, 2019|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Data will be shared initially with all Canadian Consortium on Neurodegeneration and Aging (CCNA) affiliated researchers and eventually with all interested researchers internationally.|
|Time Frame:||Canadian Consortium on Neurodegeneration and Aging (CCNA) affiliated researchers will have exclusive access to this data up to a year after data collection is complete. After that, the data will be available to any interested researcher internationally.|
Canadian Consortium on Neurodegeneration and Aging (CCNA) researchers must agree to the CCNA Publication and Data Access policy to have access to the data. They must also submit a research plan.
Non-CCNA members must apply to and be approved by the Publication and Data Access committee to be granted access to the CCNA database
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases