Clinical trial NCT03402919: Comprehensive Assessment of Neurodegeneration and Dementia
Official title: The Comprehensive Assessment of Neurodegeneration and Dementia Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Alzheimer Society of Canada
name: Sanofi
name: New Brunswick Health Research Foundation
name: Saskatchewan Health Research Foundation
name: Women's Brain Health Initiative
name: Michael Smith Foundation for Health Research
name: Alzheimer's Research UK
name: Alberta Prion Research Institute
name: Nova Scotia Health Research Foundation
name: Eli Lilly and Company
name: Canadian Nurses Foundation (CNF)
name: Ontario Brain Institute
name: Consortium pour l'Identification precoce du Maladie Alzheimer du Quebec
name: Pfizer
name: Canadian Consortium on Neurodegeneration in Aging
First posted: 2018-01-18
Enrollment: 2300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Prince George
country: Canada
facility: University of Northern British Columbia
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute
state: British Columbia
city: Vancouver
country: Canada
facility: Djavad Mowafaghian Centre for Brain Health
state: British Columbia
city: Victoria
country: Canada
facility: Island Health
state: British Columbia
city: Saint John
country: Canada
facility: St. Joseph's Hospital
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Cognitive Clinical Trials Group
state: Ontario
city: London
country: Canada
facility: Cognitive Neurology & Alzheimer's Research Centre
state: Ontario
city: London
country: Canada
facility: Gait and Brain Lab
state: Ontario
city: Ottawa
country: Canada
facility: Bruyère Research Institute
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Memory and Aging
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
city: Waterloo
country: Canada
facility: Sun Life Financial Movement Disorders and Rehabilitation Centre
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
city: Montréal
country: Canada
facility: Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)
state: Quebec
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital/McGill Memory Clinic
state: Quebec
city: Montréal
country: Canada
facility: Clinique de cognition Institut universitaire de gériatrie de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Douglas Mental Health University Institute Memory clinic
state: Quebec
city: Montréal
country: Canada
facility: McGill University Research Centre for Studies in Aging
state: Quebec
city: Québec City
country: Canada
facility: Clinique interdisciplinaire de mémoire (CIME)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Western University
name: Michael Borrie, MD
role: STUDY_DIRECTOR
References:
citation: Montero-Odasso M, Sarquis-Adamson Y, Kamkar N, Pieruccini-Faria F, Bray N, Cullen S, Mahon J, Titus J, Camicioli R, Borrie MJ, Bherer L, Speechley M. Dual-task gait speed assessments with an electronic walkway and a stopwatch in older adults. A reliability study. Exp Gerontol. 2020 Dec;142:111102. doi: 10.1016/j.exger.2020.111102. Epub 2020 Oct 2.