DementiaCOMPASS-NDNCT03402919
Comprehensive Assessment of Neurodegeneration and Dementia
An observational study of Dementia and Mild Cognitive Impairment (MCI), run by McGill University at 19 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Impairment
- How many people
- 1,573 participants
- Where
- 19 sitesCanada
- Study dates
- Jun 2016to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Canada19 sites, 12 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Eric E Smith, MD, 403.944.1594, eric.smith@albertahealthservices.ca
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Richard Camicioli, MD, (780) 248-1774, rcamicio@ualberta.ca
Krista Nelles, B. A., (780) 248-2043, knelles@ualberta.ca
- Recruiting
Veteran's Memorial Building
Halifax, Nova Scotia, B3E 2E1
Maia von Maltzahn, MD, 902-473-2495, Maia.Maltzahn@nshealth.ca
Jodie Penwarden, MFSGN, 902-473-7705, Jodie.Penwarden@nshealth.ca
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Demetrios Sahlas, MD, 905-521-2100 ext. 46373, sahlas@mcmaster.ca
- Recruiting
St. Joseph's Health Care London
London, Ontario, N6A 4V2
Michael Borrie, MD, (519) 685-4021, michael.borrie@sjhc.london.on.ca
Kayla Vander Ploeg, kayla.vanderploeg@sjhc.london.on.ca
- Recruiting
Gait and Brain Lab
London, Ontario, N6C 5J1
Manuel Montero-Odasso, MD, 519.685.4292 ext. 42369, mmontero@uwo.ca
Abbie Barron, BA, 519.685.4292 ext. 42179, Abbie.Barron@sjhc.london.on.ca
- Active, not recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec, H3G 1A4
- Recruiting
Jewish General Hospital/McGill Memory Clinic
Montreal, Quebec, H3T 1E2
Susan Vaitekunas, MD, 514 340 8222 ext. 24734, svaitekunas@jgh.mcgill.ca
Chris Hosein, M.Ed, 514 304 8222 ext. 23621, chosein@jgh.mcgill.ca
- Recruiting
Clinique de cognition Institut universitaire de gériatrie de Montréal
Montreal, Quebec, H3W 1W5
Marie-Jeanne Kergoat, MD, 514 340-3540 ext. 2811, marie-jeanne.kergoat@umontreal.ca
Sylvie Belleville, sylvie.belleville@umontreal.ca
- Active, not recruiting
Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
- Active, not recruiting
Kawartha Centre
Peterborough, Ontario, K9H 2P4
- Recruiting
Hôpital Enfant-Jésus
Québec, Quebec, G1J 1Z4
Louis Verret, MD, 418-649-5980, verretl@videotron.ca
Nancy Parent, RN, 418 649-0252 ext. 63711, nancy.parent.cha@ssss.gouv.qc.ca
- Active, not recruiting
Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1J3H5
- Active, not recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
- Active, not recruiting
University Health Network Memory Clinic
Toronto, Ontario, M5T 2S8
- Recruiting
Baycrest Clinical Unit
Toronto, Ontario, M6A 1W1
Howard Chertkow, PhD, (416)785-2500 ext. 3956, howard.chertkow@mcgill.ca
Paramjeet Sandhu, (416) 785-2500 ext. 3904, psandhu@research.baycrest.org
- Recruiting
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, V6T 1Z3
Robin Hsiung, MD, 604-822-3610, hsiung@mail.ubc.ca
Mannie Fan, M.Sc., 604-822-0550, mannie.fan@vch.ca
- Not yet recruiting
Island Health
Victoria, British Columbia, V8R 6R3
Alexandre Henri-Bhargava, MD, (778) 265-6111, alexhb@uvic.ca
Karen Coles, RN, 250.370-8111 ext. 13630, karen.coles@viha.ca
- Active, not recruiting
University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
Official title: The Comprehensive Assessment of Neurodegeneration and Dementia Study
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.
Read the detailed description
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.
- Conditions
- Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Impairment, Parkinson's Disease (PD), Lewy Body Disease(LBD), Mixed Dementia
- Keywords
- Observational, Dementia, Alzheimer's Disease, Parkinson's Disease, Biosample, Genetics, Neuropsychological, MRI, Microbiome, Plasma
- Medical subject headings
- Dementia, Cognitive Dysfunction, Parkinson Disease, Lewy Body Disease, Mixed Dementias, Frontotemporal Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study startJun 2016
- Primary completionNov 2023
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,573 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Howard Chertkow, Baycrest
- Investigators
- Michael Borrie, MD, Study director, Western UniversityNatalie Philips, PhD, Study director, Concordia University, MontrealJaspreet Bhangu, MB, Study director, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402919
- Sponsor's protocol ID
- CCNA 2015
- Acronym
- COMPASS-ND
- Status last verified
- Nov 2025
- First submitted
- 11 Jan 2018
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared initially with all Canadian Consortium on Neurodegeneration and Aging (CCNA) affiliated researchers and eventually with all interested researchers internationally.
Publications
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.
PubMed 33017671
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comprehensive Assessment of Neurodegeneration and Dementia Study
- ClinicalTrials.gov ID
- NCT03402919
- Acronym / sponsor ID
- COMPASS-ND / CCNA 2015
- Conditions
- Dementia, Mild Cognitive Impairment (MCI), Subjective Cognitive Impairment, Parkinson's Disease (PD), Lewy Body Disease(LBD), Mixed Dementia
- Keywords
- Observational, Dementia, Alzheimer's Disease, Parkinson's Disease, Biosample, Genetics, Neuropsychological, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,573 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- 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
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2023 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montreal Cognitive Assessment (MoCA) score
Time frame: 8 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 33017671Montero-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.
- This is a direct link to the study's website.Link provided by the sponsor.
- CIHR COMPASS-ND StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared initially with all Canadian Consortium on Neurodegeneration and Aging (CCNA) affiliated researchers and eventually with all interested researchers internationally.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Borrie, MD study director
Western University
Natalie Philips, PhD study director
Concordia University, Montreal
Jaspreet Bhangu, MB study director
Western University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment (MCI), run by McGill University at 19 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Howard Chertkow, MD (514 340 8222 ext. 25129, howard.chertkow@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) score (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.