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Trial record 1 of 1 for:    NCT03402919
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Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND)

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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

Tracking Information
First Submitted Date January 11, 2018
First Posted Date January 18, 2018
Last Update Posted Date October 4, 2019
Actual Study Start Date June 2016
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2018)
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.
Original Primary Outcome Measures
 (submitted: January 11, 2018)
Montreal Cognitive Assessment (MoCA) score [ Time Frame: 2 years ]
change in MoCA total score
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comprehensive Assessment of Neurodegeneration and Dementia
Official Title The Comprehensive Assessment of Neurodegeneration and Dementia Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, Saliva, Urine, Feces, Cerebrospinal Fluid
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
Condition Dementia
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 11, 2018)
2300
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03402919
Other Study ID Numbers CCNA 2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: 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

Responsible Party McGill University
Study Sponsor McGill University
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
Investigators
Study Director: Michael Borrie, MD Western University
PRS Account McGill University
Verification Date September 2019