Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND)

October 2, 2019 updated by: McGill University

The Comprehensive Assessment of Neurodegeneration and Dementia Study

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • Foothills Medical Centre
        • Contact:
        • Contact:
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Contact:
    • British Columbia
      • Prince George, British Columbia, Canada, V2N 4Z9
        • Not yet recruiting
        • University of Northern British Columbia
        • Contact:
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver Coastal Health Research Institute
        • Contact:
        • Contact:
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • Djavad Mowafaghian Centre for Brain Health
        • Contact:
        • Contact:
      • Victoria, British Columbia, Canada, V8R 6R3
        • Not yet recruiting
        • Island Health
        • Contact:
          • Alexandre Henri-Bhargava, MD
          • Phone Number: (778) 265-6111
          • Email: alexhb@uvic.ca
        • Contact:
    • New Brunswick
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Contact:
      • London, Ontario, Canada, N6A 5A5
      • London, Ontario, Canada, N6C 0A7
      • London, Ontario, Canada, N6C 0A7
      • London, Ontario, Canada, N6C 5J1
      • Ottawa, Ontario, Canada, K1N 5C8
        • Recruiting
        • Bruyère Research Institute
        • Contact:
        • Contact:
      • Peterborough, Ontario, Canada, K9H 2P4
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M6A 2E1
      • Toronto, Ontario, Canada, M4G 3E8
      • Toronto, Ontario, Canada, M5T 2S8
      • Waterloo, Ontario, Canada, N2L 3C5
        • Recruiting
        • Sun Life Financial Movement Disorders and Rehabilitation Centre
        • Contact:
          • Quincy Almeida, PhD
          • Phone Number: 2840 519 884 0710
          • Email: qalmeida@wlu.ca
        • Contact:
          • Ben Norman, M.Sc.
          • Phone Number: 3924 519-884-0710
          • Email: bnorman@wlu.ca
      • Waterloo, Ontario, Canada, N2L 3G1
        • Recruiting
        • University of Waterloo
        • Contact:
        • Contact:
    • Quebec
      • Montréal, Quebec, Canada, H2X 3H8
        • Recruiting
        • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
        • Contact:
        • Contact:
      • Montréal, Quebec, Canada, H3G 1A4
        • Active, not recruiting
        • Research Institute of the McGill University Health Centre
      • Montréal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital/McGill Memory Clinic
        • Contact:
        • Contact:
      • Montréal, Quebec, Canada, H3W 1W5
      • Montréal, Quebec, Canada, H4H 1R3
      • Montréal, Quebec, Canada, H4H 1R3
      • Québec City, Quebec, Canada, G1J 1Z4
      • Sherbrooke, Quebec, Canada, J1J3H5
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Recruiting
        • Royal University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alex Rajput, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

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

Investigators

  • Study Director: Michael Borrie, MD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCNA 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe