NCT03402919

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,573

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2016Dec 2029

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected
Last Updated

January 20, 2026

Status Verified

November 1, 2025

Enrollment Period

7.4 years

First QC Date

January 11, 2018

Last Update Submit

January 15, 2026

Conditions

Keywords

ObservationalDementiaAlzheimer's DiseaseParkinson's DiseaseBiosampleGeneticsNeuropsychologicalMRIMicrobiomePlasma

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 years

Study Arms (8)

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

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Djavad Mowafaghian Centre for Brain Health

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

Island Health

Victoria, British Columbia, V8R 6R3, Canada

NOT YET RECRUITING

Veteran's Memorial Building

Halifax, Nova Scotia, B3E 2E1, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

RECRUITING

Gait and Brain Lab

London, Ontario, N6C 5J1, Canada

RECRUITING

Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

ACTIVE NOT RECRUITING

Kawartha Centre

Peterborough, Ontario, K9H 2P4, Canada

ACTIVE NOT RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

ACTIVE NOT RECRUITING

University Health Network Memory Clinic

Toronto, Ontario, M5T 2S8, Canada

ACTIVE NOT RECRUITING

Baycrest Clinical Unit

Toronto, Ontario, M6A 1W1, Canada

RECRUITING

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

ACTIVE NOT RECRUITING

Research Institute of the McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

ACTIVE NOT RECRUITING

Jewish General Hospital/McGill Memory Clinic

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Clinique de cognition Institut universitaire de gériatrie de Montréal

Montreal, Quebec, H3W 1W5, Canada

RECRUITING

Hôpital Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

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

Sherbrooke, Quebec, J1J3H5, Canada

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Saliva, Urine, Fecal

MeSH Terms

Conditions

DementiaCognitive DysfunctionParkinson DiseaseLewy Body DiseaseMixed DementiasFrontotemporal DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesTauopathies

Study Officials

  • Michael Borrie, MD

    Western University

    STUDY DIRECTOR
  • Natalie Philips, PhD

    Concordia University, Montreal

    STUDY DIRECTOR
  • Jaspreet Bhangu, MB

    Western University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

June 1, 2016

Primary Completion

November 1, 2023

Study Completion (Estimated)

December 1, 2029

Last Updated

January 20, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Data will be shared initially with all Canadian Consortium on Neurodegeneration and Aging (CCNA) affiliated researchers and eventually with all interested researchers internationally.

Shared Documents
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.
More information

Locations