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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 : February 21, 2018
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

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 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 : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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



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


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.


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

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
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
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Eric E Smith, MD    403.944.1594    eesmith@ucalgary.ca   
Contact: Angela Zweirs, M.Sc.    403-210-5471    amzwiers@ucalgary.ca   
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Richard Camicioli, MD    (780) 248-1774    rcamicio@ualberta.ca   
Contact: Natalie Ravid, PhD    780-492-5701    ravid@ualberta.ca   
Canada, British Columbia
University of Northern British Columbia Not yet recruiting
Prince George, British Columbia, Canada, V2N 4Z9
Contact: Jacqueline Pettersen, MD    250-960-5414    pettersj@unbc.ca   
Vancouver Coastal Health Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Teresa Liu-Ambrose, PhD    604.875.4111 ext 69059    teresa.ambrose@ubc.ca   
Contact: Joey Chan, B.Sc.    604-875-4111 ext 69223    joey.chan@hiphealth.ca   
Djavad Mowafaghian Centre for Brain Health Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Robin Hsiung, MD    604-822-3610    hsiung@mail.ubc.ca   
Contact: Mannie Fan, M.Sc.    604-822-0550    mannie.fan@vch.ca   
Island Health Not yet recruiting
Victoria, British Columbia, Canada, V8R 6R3
Contact: Alexandre Henri-Bhargava, MD    (778) 265-6111    alexhb@uvic.ca   
Contact: Karen Coles, RN    250.370-8111 ext 13630    karen.coles@viha.ca   
Canada, New Brunswick
St. Joseph's Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 3L6
Contact: Pamela Jarrett, MD    506-632-5556    pamela.jarrett@horizonnb.ca   
Contact: Linda Yetman    506-632-5556    linda.yetman@horizonnb.ca   
Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Demetrios Sahlas, MD    905-521-2100 ext 46373    sahlas@mcmaster.ca   
Contact: Joanne Gorman    905 527-4322 ext 44136    gormanj@hhsc.ca   
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5A5
Cognitive Clinical Trials Group Recruiting
London, Ontario, Canada, N6C 0A7
Contact: Michael Borrie, MD    (519) 685-4021 ext 0    michael.borrie@sjhc.london.on.ca   
Contact: Sarah Best, B.Sc.    519-685-4292 ext 42567    sarah.best@sjhc.london.on.ca   
Cognitive Neurology & Alzheimer's Research Centre Not yet recruiting
London, Ontario, Canada, N6C 0A7
Contact: Elizabeth Finger, MD    519-646-6032    elizabeth.finger@lhsc.on.ca   
Contact: Sarah Jesso    519-646-6000 ext 64852    sarah.jesso@sjhc.london.on.ca   
Gait and Brain Lab Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Manuel Montero-Odasso, MD    519.685.4292 ext 42369    mmontero@uwo.ca   
Contact: Alanna Black, MSc    519.685.4292 ext 42179    alanna.black@sjhc.london.on.ca   
Bruyère Research Institute Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Stephanie Yamin, PhD    613-236-1393 ext 2380    syamin@ustpaul.ca   
Contact: Anna Voronchikhina, B. Sc.    613-562-6262 ext 1285    avoronchikhina@bruyere.org   
Kawartha Centre Recruiting
Peterborough, Ontario, Canada, K9H 2P4
Contact: Jennifer Ingram, MD    705-749-3906    jenny@kawarthacentre.ca   
Contact: Sandra Trudell, B.Sc.    705-749-3906 ext 211    sandra@kawarthacentre.com   
The Centre for Memory and Aging Active, not recruiting
Toronto, Ontario, Canada, M4G 3E8
Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
University Health Network Memory Clinic Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Carmela Tartaglia, MD    416-507-6879    carmela.tartaglia@utoronto.ca   
Contact: Behnaz Ghazanfari, MD    416-603-5800 ext 5910    Behnaz.Ghazanfari@uhnresearch.ca   
Baycrest Not yet recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Nicole Anderson, PhD    (416)785-2500 ext 3366    nanderson@research.baycrest.org   
Contact: Carol Greenwood, PhD    (416) 785-2500 ext 2785    carol.greenwood@utoronto.ca   
Sun Life Financial Movement Disorders and Rehabilitation Centre Active, not recruiting
Waterloo, Ontario, Canada, N2L 3C5
University of Waterloo Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Middleton Laura, Ph.D.    519-888-4567 ext 33045    lmiddlet@uwaterloo.ca   
Contact: Kayla Regan, M.Sc.    519-888-4567 ext 38548    kregan@uwaterloo.ca   
Canada, Quebec
the MoCA Clinic & Institute Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Contact: Ziad Nasreddine, MD    450-672-7766    ziad.nasreddine@mocaclinic.ca   
Contact: Kathleen Gallant, OTN    (450) 672-7766 ext 222    kathleen.gallant@mocaclinic.ca   
Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM) Recruiting
Montréal, Quebec, Canada, H2X 3H8
Contact: Josée Filion, MD    514 890-8000    filion.josee1@videotron.ca   
Contact: Marie-Ève Bourassa, PhD    514 890-8000    marieevebourassa@hotmail.com   
Research Institute of the McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: Ronald Postuma, MD    514-934-8026    ron.postuma@mcgill.ca   
Contact: Amélie Pelletier, PhD    514-934-1934 ext 45462    amelie.pelletier@mail.mcgill.ca   
Jewish General Hospital/McGill Memory Clinic Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Susan Vaitekunas, MD    514 340 8222 ext 24734    svaitekunas@jgh.mcgill.ca   
Contact: Chris Hosein, M.Ed    514 304 8222 ext 23621    chosein@jgh.mcgill.ca   
Clinique de cognition Institut universitaire de gériatrie de Montréal Recruiting
Montréal, Quebec, Canada, H3W 1W5
Contact: Marie-Jeanne Kergoat, MD    514 340-3540 ext 2811    marie-jeanne.kergoat@umontreal.ca   
Contact: Karine Thorn, MN    514 340-2800 ext 3253    karine.thorn@criugm.qc.ca   
Douglas Mental Health University Institute Memory clinic Recruiting
Montréal, Quebec, Canada, H4H 1R3
Contact: Vasavan Nair, MD    514 762-3035    vasavan.nair@douglas.mcgill.ca   
Contact: Elena Lebedeva, Ph. D.    514-761-6131 ext 3451    elena.lebedeva@douglas.mcgill.ca   
McGill University Research Centre for Studies in Aging Recruiting
Montréal, Quebec, Canada, H4H 1R3
Contact: Serge Gauthier, MD    514-766-2010    serge.gauthier@mcgill.ca   
Contact: Monica Shin, M. Sc.    514-766-2010    monica.shin@mail.mcgill.ca   
Clinique interdisciplinaire de mémoire (CIME) Recruiting
Québec City, Quebec, Canada, G1J 1Z4
Contact: Louis Verret, MD    418-649-5980    verretl@videotron.ca   
Contact: Nancy Parent, RN    418 649-0252 ext 63711    nancy.parent.cha@ssss.gouv.qc.ca   
Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS Recruiting
Sherbrooke, Quebec, Canada, J1J3H5
Contact: Tamas Fulop, MD    819 780-2220 ext 45293    tamas.fulop@usherbrooke.ca   
Contact: Mylène Lafrance, PhD    (819) 780-2220 ext 46344    mylene.lafrance@USherbrooke.ca   
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Andrew Kirk, MD    306-844-1421    andrew.kirk@usask.ca   
Contact: Andrhea Nocon, RN    (306) 229-7977    andrhea.nocon@usask.ca   
Sub-Investigator: Alex Rajput, MD         
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)

Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT03402919     History of Changes
Other Study ID Numbers: CCNA 2015
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: January 2018
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


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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes