Comprehensive Assessment of Neurodegeneration and Dementia

Dementia Clinical Trial

— COMPASS-ND  

Official title:

The Comprehensive Assessment of Neurodegeneration and Dementia Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402919
• Other study ID #: CCNA 2015
• Status: Recruiting
• Start date: June 2016
• Est. completion date: September 2023

Study information

• Verified date: September 2019
• Source: McGill University
• Contact: Howard Chertkow, MD
• Phone: 514 340 8222
• Email: howard.chertkow[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a 5-year observational study recruiting sixteen hundred and fifty individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group of six hundred and fifty aged matched individuals without cognitive deficits. Participants will be recruited at sites across Canada and will undergo assessments and provide biological samples at baseline and two years after baseline.

Description:

This is a 5-year observational study. Sixteen-hundred and fifty (1650) subjects, between the ages of 50 and 90,years old, 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 650 healthy elderly subjects without cognitive complaints or deficits, will be enrolled into this study from up to 30 centres across Canada. All subjects involved in the study will undergo 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 will be collected, stored, and analyzed. Basic follow-up determining if there has been any change in their diagnosis will be carried out annually and longitudinal re-evaluation will be carried out after two years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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)

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/Lewy Body Dementia 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

• MoCA < 13

• Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure

Related Conditions & MeSH terms

• Dementia
• Nerve Degeneration

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Cognitive Clinical Trials Group	London	Ontario
Canada	Cognitive Neurology & Alzheimer's Research Centre	London	Ontario
Canada	Gait and Brain Lab	London	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)	Montréal	Quebec
Canada	Clinique de cognition Institut universitaire de gériatrie de Montréal	Montréal	Quebec
Canada	Douglas Mental Health University Institute Memory clinic	Montréal	Quebec
Canada	Jewish General Hospital/McGill Memory Clinic	Montréal	Quebec
Canada	McGill University Research Centre for Studies in Aging	Montréal	Quebec
Canada	Research Institute of the McGill University Health Centre	Montréal	Quebec
Canada	Bruyère Research Institute	Ottawa	Ontario
Canada	Kawartha Centre	Peterborough	Ontario
Canada	University of Northern British Columbia	Prince George	British Columbia
Canada	Clinique interdisciplinaire de mémoire (CIME)	Québec City	Quebec
Canada	St. Joseph's Hospital	Saint John	New Brunswick
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS	Sherbrooke	Quebec
Canada	Baycrest	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	The Centre for Memory and Aging	Toronto	Ontario
Canada	University Health Network Memory Clinic	Toronto	Ontario
Canada	Djavad Mowafaghian Centre for Brain Health	Vancouver	British Columbia
Canada	Vancouver Coastal Health Research Institute	Vancouver	British Columbia
Canada	Island Health	Victoria	British Columbia
Canada	Sun Life Financial Movement Disorders and Rehabilitation Centre	Waterloo	Ontario
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (17)

Lead Sponsor

Collaborator

McGill University

Alberta Prion Research Institute, Alzheimer Society of Canada, Alzheimer's Research UK, Canadian Consortium on Neurodegeneration in Aging, Canadian Institutes of Health Research (CIHR), Canadian Nurses Foundation (CNF), Consortium pour l'Identification precoce du Maladie Alzheimer du Quebec, Eli Lilly and Company, Michael Smith Foundation for Health Research, New Brunswick Health Research Foundation, Nova Scotia Health Research Foundation, Ontario Brain Institute, Pfizer, Sanofi, Saskatchewan Health Research Foundation, Women's Brain Health Initiative

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years