An observational study in Dementia, Mild Cognitive Impairment (MCI) and Subjective Cognitive Impairment, sponsored by McGill University. Recruiting at 19 sites in Canada. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by McGill University · Observational
This is a longitudinal observational study recruiting individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group without cognitive deficits. Participants are/will be recruited at sites across Canada and will undergo assessments, neuroimaging, and biological sample collection.
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 1,573 is above the median of 256 across 553 observational studies indexed under Dementia.
Browse Dementia studies →McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
2300 English and/or French-speaking participants recruited from across Canada in the following groups:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants with no subjective or objective cognitive deficits or decline.
Participants with a complaint of subjective cognitive impairment, but no objective evidence of such.
Participants with objective evidence of cognitive impairment, but it does not impact on daily function.
Participants meeting criteria of MCI who also show signs of cerebrovascular disease on imaging but have no history of stroke.
Participants with dementia of the Alzheimer's type according to the National Institute of Aging-Alzheimer's Association criteria
Participants with dementia and evidence of more than one etiology.
Participants with Parkinson's disease who show mild or moderate cognitive impairment and/or dementia.
Participants with behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, or corticobasal syndrome
Montreal Cognitive Assessment (MoCA) score
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.
Time frame: 8 years
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be shared initially with all Canadian Consortium on Neurodegeneration and Aging (CCNA) affiliated researchers and eventually with all interested researchers internationally.
Supporting information: Study protocol, Analytic code
Time frame: The data is currently available.
Access criteria: Reaserchers who which to access the database will be required to create an account through CCNA and demonstrate their research credentials and their affiliation to a recognized research organization. Users must confirm that their intended use of data respects CCNA policies and applicable ethical, legal, and data governance requirements. Researchers are further required to hold data secure, not to attempt the re-identification of research participants, and not to perform research that could cause communities to experience stigmatization or discrimination.
Data sharing details ↗ · ccna-ccnv.ca
Ran from Jun 2016 to primary completion in Nov 2023, 89 months.
Of 271 non-industry observational studies under Dementia, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 202. This study's 89 months is above that.
Counting every sponsor, half of 293 studies reached it within 67 months; a quarter within 29 and three quarters within 188.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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