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Comprehensive Assessment of Neurodegeneration and Dementia

NCT03402919 · McGill University
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Official title
The Comprehensive Assessment of Neurodegeneration and Dementia Study
About this study
This is a longitudinal observational study that started in Phase I with the recruitment of 1173 participants between the ages of 50 and 90 years 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 healthy elderly subjects without cognitive complaints or deficits. These participants were enrolled in 30 different centres across Canada. All subjects involved in the study underwent 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 were collected, stored, and analyzed. Longitudinal follow-up determining if there has been any change in their diagnosis was carried out annually and longitudinal re-evaluation was carried out at two times: Time 2 and Time 3. In Time 3, 400 participants across the non-dementia cohorts (Cognitively Unimpaired, Subjective Cognitive Impairment, Mild Cognitive Impairment, Mild Cognitive Impairment with a Vascular Component, Parkinson's Disease with no Cognitive Impairment, Parkinson's Disease with Mild Cognitive Impairment) with up to 12 years of education will be recruited.
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) * Up to 12 years of education * Fits into one of the following groups: Cognitively Unimpaired, Subjective Cognitive Impairment, Mild Cognitive Impairment, Vascular Mild Cognitive Impairment, Parkinson's Disease, Parkinson's Disease with Mild Cognitive Impairment 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 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 * Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure
Study design
Enrollment target: 1573 participants
Age groups: adult, older_adult
Timeline
Starts: 2016-06
Estimated completion: 2029-12
Last updated: 2026-01-20
Primary outcomes
  • Montreal Cognitive Assessment (MoCA) score (8 years)
Sponsor
McGill University · other
With: Canadian Institutes of Health Research (CIHR), Alzheimer Society of Canada, Sanofi, New Brunswick Health Research Foundation, Saskatchewan Health Research Foundation, Michael Smith Foundation for Health Research, Nova Scotia Health Research Foundation, Eli Lilly and Company, Canadian Nurses Foundation (CNF), Ontario Brain Institute, Pfizer, Canadian Consortium on Neurodegeneration in Aging
Contacts & investigators
ContactHoward Chertkow, MD · contact · howard.chertkow@mcgill.ca · 514 340 8222
ContactRandi Pilon · contact · Randi.Pilon@ladydavis.ca · 514 8339709
InvestigatorMichael Borrie, MD · study_director, Western University
InvestigatorNatalie Philips, PhD · study_director, Concordia University, Montreal
InvestigatorJaspreet Bhangu, MB · study_director, Western University
All locations (19)
University of CalgaryRecruiting
Calgary, Alberta, Canada
University of Alberta HospitalRecruiting
Edmonton, Alberta, Canada
Djavad Mowafaghian Centre for Brain HealthRecruiting
Vancouver, British Columbia, Canada
Island HealthNot Yet Recruiting
Victoria, British Columbia, Canada
Veteran's Memorial BuildingRecruiting
Halifax, Nova Scotia, Canada
Hamilton General HospitalRecruiting
Hamilton, Ontario, Canada
St. Joseph's Health Care LondonRecruiting
London, Ontario, Canada
Gait and Brain LabRecruiting
London, Ontario, Canada
Bruyère Research InstituteActive Not Recruiting
Ottawa, Ontario, Canada
Kawartha CentreActive Not Recruiting
Peterborough, Ontario, Canada
Sunnybrook Health Sciences CentreActive Not Recruiting
Toronto, Ontario, Canada
University Health Network Memory ClinicActive Not Recruiting
Toronto, Ontario, Canada
Baycrest Clinical UnitRecruiting
Toronto, Ontario, Canada
University of WaterlooActive Not Recruiting
Waterloo, Ontario, Canada
Research Institute of the McGill University Health CentreActive Not Recruiting
Montreal, Quebec, Canada
Jewish General Hospital/McGill Memory ClinicRecruiting
Montreal, Quebec, Canada
Clinique de cognition Institut universitaire de gériatrie de MontréalRecruiting
Montreal, Quebec, Canada
Hôpital Enfant-JésusRecruiting
Québec, Quebec, Canada
Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUSActive Not Recruiting
Sherbrooke, Quebec, Canada
Comprehensive Assessment of Neurodegeneration and Dementia · TrialPath