Recruiting

Observational StudyComprehensive Assessment of Neurodegeneration and Dementia

Sponsor:

McGill University

Code:

NCT03402919

Conditions

Dementia

Mild Cognitive Impairment (MCI)

Subjective Cognitive Impairment

Parkinson's Disease (PD)

Lewy Body Disease(LBD)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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. Participants are/will be recruited at sites across Canada and will undergo assessments, neuroimaging, and biological sample collection.

Conditions

Dementia

Mild Cognitive Impairment (MCI)

Subjective Cognitive Impairment

Parkinson's Disease (PD)

Lewy Body Disease(LBD)

Study ID

NCT03402919

Start date

Jun, 2016

Status verified date

Nov, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Nov, 2023

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1573 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

Montreal Cognitive Assessment (MoCA) score [ Time Frame: 8 years ]

Central Contacts and Locations

Central contacts

Howard Chertkow, MD

514 340 8222 howard.chertkow@mcgill.ca

Randi Pilon

514 8339709 Randi.Pilon@ladydavis.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Eric E Smith, MD

403.944.1594 eric.smith@albertahealthservices.ca

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Richard Camicioli, MD

(780) 248-1774 rcamicio@ualberta.ca

Krista Nelles, B. A.

(780) 248-2043 knelles@ualberta.ca

Djavad Mowafaghian Centre for Brain Health

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Contacts

Robin Hsiung, MD

604-822-3610 hsiung@mail.ubc.ca

Mannie Fan, M.Sc.

604-822-0550 mannie.fan@vch.ca

Veteran's Memorial Building

Recruiting

Halifax, Nova Scotia, Canada, B3E 2E1

Contacts

Maia von Maltzahn, MD

902-473-2495 Maia.Maltzahn@nshealth.ca

Jodie Penwarden, MFSGN

902-473-7705 Jodie.Penwarden@nshealth.ca

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Demetrios Sahlas, MD

905-521-2100 sahlas@mcmaster.ca

St. Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Michael Borrie, MD

(519) 685-4021 michael.borrie@sjhc.london.on.ca

Kayla Vander Ploeg

kayla.vanderploeg@sjhc.london.on.ca

Gait and Brain Lab

Recruiting

London, Ontario, Canada, N6C 5J1

Contacts

Manuel Montero-Odasso, MD

519.685.4292 mmontero@uwo.ca

Abbie Barron, BA

519.685.4292 Abbie.Barron@sjhc.london.on.ca

Baycrest Clinical Unit

Recruiting

Toronto, Ontario, Canada, M6A 1W1

Contacts

Howard Chertkow, PhD

(416)785-2500 howard.chertkow@mcgill.ca

Paramjeet Sandhu

(416) 785-2500 psandhu@research.baycrest.org

Jewish General Hospital/McGill Memory Clinic

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Susan Vaitekunas, MD

514 340 8222 svaitekunas@jgh.mcgill.ca

Chris Hosein, M.Ed

514 304 8222 chosein@jgh.mcgill.ca

Clinique de cognition Institut universitaire de gériatrie de Montréal

Recruiting

Montreal, Quebec, Canada, H3W 1W5

Contacts

Marie-Jeanne Kergoat, MD

514 340-3540 marie-jeanne.kergoat@umontreal.ca

Sylvie Belleville

sylvie.belleville@umontreal.ca

Hôpital Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Louis Verret, MD

418-649-5980 verretl@videotron.ca

Nancy Parent, RN

418 649-0252 nancy.parent.cha@ssss.gouv.qc.ca

More Information

Sponsor

McGill University

Last update posted

Jan 20, 2026

Last verified

Nov, 2025

Keywords

Observational
Dementia
Alzheimer's Disease
Parkinson's Disease
Biosample
Genetics
Neuropsychological
MRI
Microbiome
Plasma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by McGill University on 2026-01-20.