|Comprehensive Assessment of Neurodegeneration and Dementia
|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.
|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.
|Observational Model: Cohort|
Time Perspective: Prospective
|Retention: Samples With DNA|
Blood, Saliva, Urine, Feces, Cerebrospinal Fluid
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
- 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
|Same as current|
|September 2023 (Final data collection date for primary outcome measure)
- 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)
- 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
|Sexes Eligible for Study:||All|
|50 Years to 90 Years (Adult, Older Adult)
|Studies a U.S. FDA-regulated Drug Product: ||No|
|Studies a U.S. FDA-regulated Device Product: ||No|
|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|
|Supporting Materials:||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.|
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
- Canadian Institutes of Health Research (CIHR)
- Alzheimer Society of Canada
- 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
- Canadian Consortium on Neurodegeneration in Aging
|Study Director:||Michael Borrie, MD||Western University|