Comprehensive Assessment of Neurodegeneration and Dementia

• Conditions: Dementia

• Registration Number: NCT03402919
• Lead Sponsor: McGill University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Status Verified: 2019-09
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA) score	2 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.

Trial Locations

Locations (29)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Northern British Columbia; 🇨🇦 Prince George, British Columbia, Canada

Vancouver Coastal Health Research Institute; 🇨🇦 Vancouver, British Columbia, Canada

Djavad Mowafaghian Centre for Brain Health; 🇨🇦 Vancouver, British Columbia, Canada

Island Health; 🇨🇦 Victoria, British Columbia, Canada

St. Joseph's Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Cognitive Clinical Trials Group; 🇨🇦 London, Ontario, Canada

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