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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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Alzheimer Society of Canada
Sanofi
New Brunswick Health Research Foundation
Saskatchewan Health Research Foundation
Women's Brain Health Initiative
Michael Smith Foundation for Health Research
Alzheimer's Research UK
Alberta Prion Research Institute
Nova Scotia Health Research Foundation
Eli Lilly and Company
Canadian Nurses Foundation (CNF)
Ontario Brain Institute
Consortium pour l'Identification precoce du Maladie Alzheimer du Quebec
Pfizer
Canadian Consortium on Neurodegeneration in Aging
Information provided by (Responsible Party):
McGill University

Study Description
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Brief Summary:
This is a 5-year observational study recruiting sixteen hundred and fifty individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group of six hundred and fifty aged matched individuals without cognitive deficits. Participants will be recruited at sites across Canada and will undergo assessments and provide biological samples at baseline and two years after baseline.

Condition or disease
Dementia

Detailed Description:
This is a 5-year observational study. Sixteen-hundred and fifty (1650) subjects, between the ages of 50 and 90,years old, with Subjective Cognitive Impairment, Mild Cognitive Impairment, Mild Cognitive Impairment with subcortical vascular lesions, Alzheimer's Disease, Mixed dementia, Lewy Body Dementia, Parkinson's Disease Dementia, Parkinson's Disease with Mild Cognitive Impairment and Frontotemporal Dementia, as well as 650 healthy elderly subjects without cognitive complaints or deficits, will be enrolled into this study from up to 30 centres across Canada. All subjects involved in the study will undergo rigorous evaluations at baseline, including clinical assessment, neuropsychological assessment, genomics and neuroimaging. Biological samples from blood, saliva, urine, fecal matter, buccal cells and cerebrospinal fluid will be collected, stored, and analyzed. Basic follow-up determining if there has been any change in their diagnosis will be carried out annually and longitudinal re-evaluation will be carried out after two years.
Study Design
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Study Type : Observational
Estimated Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.
Vascular MCI
Participants meeting criteria of MCI who also show signs of cerebrovascular disease on imaging but have no history of stroke.
Alzheimer's Disease
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


Outcome Measures
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Primary Outcome Measures :
  1. 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
Blood, Saliva, Urine, Feces, Cerebrospinal Fluid

Eligibility Criteria
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Information from the National Library of Medicine

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.


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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
Study Population

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
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Howard Chertkow, MD 514 340 8222 ext 25129 howard.chertkow@mcgill.ca
Contact: Victor Whitehead, MSW 514 340 8222 ext 25267 victor.whitehead@ladydavis.ca

Locations
Show Show 29 study locations
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
Alzheimer Society of Canada
Sanofi
New Brunswick Health Research Foundation
Saskatchewan Health Research Foundation
Women's Brain Health Initiative
Michael Smith Foundation for Health Research
Alzheimer's Research UK
Alberta Prion Research Institute
Nova Scotia Health Research Foundation
Eli Lilly and Company
Canadian Nurses Foundation (CNF)
Ontario Brain Institute
Consortium pour l'Identification precoce du Maladie Alzheimer du Quebec
Pfizer
Canadian Consortium on Neurodegeneration in Aging
Investigators
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Study Director: Michael Borrie, MD Western University
  Study Documents (Full-Text)

Documents provided by McGill University:
Study Protocol and Statistical Analysis Plan  [PDF] May 15, 2017
Informed Consent Form: Study Participant Informed Consent Form  [PDF] May 15, 2017
Informed Consent Form: Study Partner Informed Consent Form  [PDF] May 15, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT03402919    
Other Study ID Numbers: CCNA 2015
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.
Supporting Materials: Study Protocol
Analytic Code
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.
Access Criteria:

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Nerve Degeneration
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes