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COMPASS-ND: Comprehensive Assessment of Neurodegeneration and Dementia

Sponsor
McGill University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03402919
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), Alzheimer Society of Canada (Other), Sanofi (Industry), New Brunswick Health Research Foundation (Other), Saskatchewan Health Research Foundation (Other), Women's Brain Health Initiative (Other), Michael Smith Foundation for Health Research (Other), Alzheimer's Research UK (Other), Alberta Prion Research Institute (Other), Nova Scotia Health Research Foundation (Other), Eli Lilly and Company (Industry), Canadian Nurses Foundation (CNF) (Other), Ontario Brain Institute (Other), Consortium pour l'Identification precoce du Maladie Alzheimer du Quebec (Other), Pfizer (Industry), Canadian Consortium on Neurodegeneration in Aging (Other)
2,300
Enrollment
29
Locations
87
Anticipated Duration (Months)
79.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    2300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Comprehensive Assessment of Neurodegeneration and Dementia Study
    Actual Study Start Date :
    Jun 1, 2016
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Montreal Cognitive Assessment (MoCA) score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Foothills Medical Centre Calgary Alberta Canada T2N 2T9
    2 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    3 University of Northern British Columbia Prince George British Columbia Canada V2N 4Z9
    4 Vancouver Coastal Health Research Institute Vancouver British Columbia Canada V5Z 1M9
    5 Djavad Mowafaghian Centre for Brain Health Vancouver British Columbia Canada V6T 1Z3
    6 Island Health Victoria British Columbia Canada V8R 6R3
    7 St. Joseph's Hospital Saint John New Brunswick Canada E2L 3L6
    8 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2
    9 London Health Sciences Centre London Ontario Canada N6A 5A5
    10 Cognitive Clinical Trials Group London Ontario Canada N6C 0A7
    11 Cognitive Neurology & Alzheimer's Research Centre London Ontario Canada N6C 0A7
    12 Gait and Brain Lab London Ontario Canada N6C 5J1
    13 Bruyère Research Institute Ottawa Ontario Canada K1N 5C8
    14 Kawartha Centre Peterborough Ontario Canada K9H 2P4
    15 The Centre for Memory and Aging Toronto Ontario Canada M4G 3E8
    16 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    17 University Health Network Memory Clinic Toronto Ontario Canada M5T 2S8
    18 Baycrest Toronto Ontario Canada M6A 2E1
    19 Sun Life Financial Movement Disorders and Rehabilitation Centre Waterloo Ontario Canada N2L 3C5
    20 University of Waterloo Waterloo Ontario Canada N2L 3G1
    21 Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM) Montréal Quebec Canada H2X 3H8
    22 Research Institute of the McGill University Health Centre Montréal Quebec Canada H3G 1A4
    23 Jewish General Hospital/McGill Memory Clinic Montréal Quebec Canada H3T 1E2
    24 Clinique de cognition Institut universitaire de gériatrie de Montréal Montréal Quebec Canada H3W 1W5
    25 Douglas Mental Health University Institute Memory clinic Montréal Quebec Canada H4H 1R3
    26 McGill University Research Centre for Studies in Aging Montréal Quebec Canada H4H 1R3
    27 Clinique interdisciplinaire de mémoire (CIME) Québec City Quebec Canada G1J 1Z4
    28 Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS Sherbrooke Quebec Canada J1J3H5
    29 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8

    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

    • Study Director: Michael Borrie, MD, Western University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    McGill University
    ClinicalTrials.gov Identifier:
    NCT03402919
    Other Study ID Numbers:
    • CCNA 2015
    First Posted:
    Jan 18, 2018
    Last Update Posted:
    Oct 4, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dementia
    Nerve Degeneration

    Study Results

    No Results Posted as of Oct 4, 2019