Comprehensive Assessment of Neurodegeneration and Dementia

NCT ID: NCT03402919

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1573 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Dementia Mild Cognitive Impairment (MCI) Subjective Cognitive Impairment Parkinson's Disease (PD) Lewy Body Disease(LBD) Mixed Dementia Frontotemporal Dementia (FTD) Alzheimer Disease (AD) Cognitively Unimpaired Subjective Cognitive Decline (SCD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal healthy elderly

participants with no subjective or objective cognitive deficits or decline.

No interventions assigned to this group

Subjective Cognitive Decline

Participants with a complaint of subjective cognitive impairment, but no objective evidence of such.

No interventions assigned to this group

Mild Cognitive Impairment (MCI)

Participants with objective evidence of cognitive impairment, but it does not impact on daily function.

No interventions assigned to this group

Vascular MCI

Participants meeting criteria of MCI who also show signs of cerebrovascular disease on imaging but have no history of stroke.

No interventions assigned to this group

Alzheimer's Disease

Participants with dementia of the Alzheimer's type according to the National Institute of Aging-Alzheimer's Association criteria

No interventions assigned to this group

Dementia of Mixed Etiology

Participants with dementia and evidence of more than one etiology.

No interventions assigned to this group

Lewy Body/Parkinson's spectrum

Participants with Parkinson's disease who show mild or moderate cognitive impairment and/or dementia.

No interventions assigned to this group

Frontotemporal dementia (FTD) spectrum

Participants with behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, or corticobasal syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Alzheimer Society of Canada

OTHER

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

New Brunswick Health Research Foundation

OTHER

Sponsor Role collaborator

Saskatchewan Health Research Foundation

OTHER

Sponsor Role collaborator

Michael Smith Foundation for Health Research

OTHER

Sponsor Role collaborator

Nova Scotia Health Research Foundation

OTHER_GOV

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Canadian Nurses Foundation (CNF)

OTHER

Sponsor Role collaborator

Ontario Brain Institute

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Canadian Consortium on Neurodegeneration in Aging

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role lead

Responsible Party

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Howard Chertkow

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Borrie, MD

Role: STUDY_DIRECTOR

Western University

Natalie Philips, PhD

Role: STUDY_DIRECTOR

Concordia University, Montreal

Jaspreet Bhangu, MB

Role: STUDY_DIRECTOR

Western University

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, Canada

Site Status RECRUITING

Island Health

Victoria, British Columbia, Canada

Site Status NOT_YET_RECRUITING

Veteran's Memorial Building

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Joseph's Health Care London

London, Ontario, Canada

Site Status RECRUITING

Gait and Brain Lab

London, Ontario, Canada

Site Status RECRUITING

Bruyère Research Institute

Ottawa, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Kawartha Centre

Peterborough, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

University Health Network Memory Clinic

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Baycrest Clinical Unit

Toronto, Ontario, Canada

Site Status RECRUITING

University of Waterloo

Waterloo, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Jewish General Hospital/McGill Memory Clinic

Montreal, Quebec, Canada

Site Status RECRUITING

Clinique de cognition Institut universitaire de gériatrie de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Hôpital Enfant-Jésus

Québec, Quebec, Canada

Site Status RECRUITING

Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Countries

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Canada

Central Contacts

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Howard Chertkow, MD

Role: CONTACT

514 340 8222 ext. 25129

Randi Pilon

Role: CONTACT

514 8339709

Facility Contacts

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Eric E Smith, MD

Role: primary

403.944.1594

Richard Camicioli, MD

Role: primary

(780) 248-1774

Krista Nelles, B. A.

Role: backup

(780) 248-2043

Robin Hsiung, MD

Role: primary

604-822-3610

Mannie Fan, M.Sc.

Role: backup

604-822-0550

Alexandre Henri-Bhargava, MD

Role: primary

(778) 265-6111

Karen Coles, RN

Role: backup

250.370-8111 ext. 13630

Maia von Maltzahn, MD

Role: primary

902-473-2495

Jodie Penwarden, MFSGN

Role: backup

902-473-7705

Demetrios Sahlas, MD

Role: primary

905-521-2100 ext. 46373

Michael Borrie, MD

Role: primary

(519) 685-4021

Kayla Vander Ploeg

Role: backup

Manuel Montero-Odasso, MD

Role: primary

519.685.4292 ext. 42369

Abbie Barron, BA

Role: backup

519.685.4292 ext. 42179

Howard Chertkow, PhD

Role: primary

(416)785-2500 ext. 3956

Paramjeet Sandhu

Role: backup

(416) 785-2500 ext. 3904

Susan Vaitekunas, MD

Role: primary

514 340 8222 ext. 24734

Chris Hosein, M.Ed

Role: backup

514 304 8222 ext. 23621

Marie-Jeanne Kergoat, MD

Role: primary

514 340-3540 ext. 2811

Sylvie Belleville

Role: backup

Louis Verret, MD

Role: primary

418-649-5980

Nancy Parent, RN

Role: backup

418 649-0252 ext. 63711

References

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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.

Reference Type DERIVED
PMID: 33017671 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Study Participant Informed Consent Form

View Document

Document Type: Informed Consent Form: Study Partner Informed Consent Form

View Document

Related Links

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https://ccna-ccnv.ca/compass-nd-study/

This is a direct link to the study's website.

Other Identifiers

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CCNA 2015

Identifier Type: -

Identifier Source: org_study_id

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