Comprehensive assessment of neurodegeneration and dementia

The Comprehensive Assessment of Neurodegeneration and Dementia Study

This project will collect brain scans, cognitive tests, and biological samples over time to see how dementia and related conditions progress in adults aged 50–90, including people with Parkinson's and people without cognitive problems.

Quick facts

• Study type: Observational
• Enrollment: 1573 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: McGill University (other)
• Locations: 19 sites (Calgary, Alberta and 18 other locations)
• Trial ID: NCT03402919 on ClinicalTrials.gov

What this trial studies

This is a multi-center, longitudinal observational program enrolling adults aged 50–90 with a range of diagnoses (subjective cognitive impairment, MCI, Alzheimer's, Lewy body disease, Parkinson's disease with and without cognitive impairment, and healthy controls) across sites in Canada. Participants receive detailed baseline clinical and neuropsychological evaluations, genomics testing, and multimodal neuroimaging. Biological samples (blood, saliva, urine, feces, buccal cells, and cerebrospinal fluid) are collected, stored, and analyzed, with annual follow-up visits and planned re-evaluations at two later timepoints. A Time 3 substudy will recruit ~400 participants from non-dementia cohorts to extend longitudinal follow-up and biomarker characterization.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–90 who have subjective or objective cognitive impairment or are cognitively unimpaired controls, who speak English or French, can travel to a Canadian study site, have up to 12 years of education as specified, and can provide a study partner for corroborative information.

Not a fit: Patients with other significant chronic brain diseases (for example advanced leukoencephalopathy, multiple sclerosis, major developmental handicap), active malignant disease, inability to consent or lack of a study partner, or those living outside the geographic catchment of participating Canadian sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this program could improve understanding of how different dementias progress and help identify biological markers that enable earlier or more accurate diagnosis.

How similar studies have performed: Other longitudinal cohort efforts (for example ADNI and similar dementia cohorts) have successfully identified imaging and fluid biomarkers, and this Canadian multi-center effort builds on that precedent while broadening diagnostic groups and sample types.

Eligibility criteria

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

Where this trial is running

Calgary, Alberta and 18 other locations

• University of Calgary — Calgary, Alberta, Canada (RECRUITING)
• University of Alberta Hospital — Edmonton, Alberta, Canada (RECRUITING)
• Djavad Mowafaghian Centre for Brain Health — Vancouver, British Columbia, Canada (RECRUITING)
• Island Health — Victoria, British Columbia, Canada (NOT_YET_RECRUITING)
• Veteran's Memorial Building — Halifax, Nova Scotia, Canada (RECRUITING)
• Hamilton General Hospital — Hamilton, Ontario, Canada (RECRUITING)
• St. Joseph's Health Care London — London, Ontario, Canada (RECRUITING)
• Gait and Brain Lab — London, Ontario, Canada (RECRUITING)
• Bruyère Research Institute — Ottawa, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Kawartha Centre — Peterborough, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• University Health Network Memory Clinic — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Baycrest Clinical Unit — Toronto, Ontario, Canada (RECRUITING)
• University of Waterloo — Waterloo, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada (ACTIVE_NOT_RECRUITING)
• Jewish General Hospital/McGill Memory Clinic — Montreal, Quebec, Canada (RECRUITING)
• Clinique de cognition Institut universitaire de gériatrie de Montréal — Montreal, Quebec, Canada (RECRUITING)
• Hôpital Enfant-Jésus — Québec, Quebec, Canada (RECRUITING)
• Centre de recherche sur le vieillissement CIUSSS de l'Estrie-CHUS — Sherbrooke, Quebec, Canada (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Howard Chertkow, MD

Conditions: Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment, Parkinson's Disease, Lewy Body Disease, Mixed Dementia, Frontotemporal Dementia, Alzheimer Disease