NCT01800214Active, not recruiting
The Sunnybrook Dementia Study
Prospective Neuroimaging, Cognition and Behavioural Study of Alzheimer's, Vascular, Parkinson's, Frontotemporal and Mixed Dementias
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
The prospect of disease-modifying therapies in the pipeline for Alzheimer's Disease (AD) has intensified efforts to use brain imaging more effectively for diagnosis and monitoring of dementing illnesses. There is also emerging awareness of the destructive interplay between AD and Cerebrovascular Disease (CVD) in our aging population; both disorders share common vascular risk factors and may respond to similar prevention treatments. Brain mapping techniques capitalize on the fact that different neurodegenerative diseases target particular brain areas. Brain shrinkage and stroke disease can be quantified on Magnetic Resonance Imaging (MRI) using computerized analysis. This ongoing study applies advanced MR imaging analysis, genetic testing and standardized cognitive and functional assessments done at yearly intervals to measure and monitor longitudinal change in patients with AD, vascular and other neurodegenerative diseases and potentially to measure modifying effects of emerging therapies. Nearly 1800 patients (Mild Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and over 140 normal elderly have already been enrolled, with 180 autopsies. This study utilizes specialized imaging analysis software packages to reliably quantify brain tissue volumes and small vessel disease, the most common type of CVD. The SDS also investigates other potential biomarkers of dementia such as eye-tracking, optical coherence tomography, gait and balance, and the gut microbiome to explore their clinical utility. Results from this study will help to improve diagnosis, to customize treatment, and to better monitor disease-modifying therapies currently under investigation should they become applicable to everyday practice.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1800 (estimated)
- First submitted
- 25 Feb 2013
- Start date
- Sept 1995
- Primary completion date
- Jul 2026
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Frontotemporal dementia, Parkinson disease
- NCT number
- NCT01800214
What you commit to
- Study type: Observational
- Planned participants: 1800
- From Sept 1995 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patient Inclusion Criteria (General):
- Age between 40 and 90 (inclusive)
- Fluent in English
- Completed 8 years of education or higher
- Visual and auditory acuity adequate for neuropsychological testing
- Mini-Mental State Exam (MMSE) score ≥ 16
- Patient Exclusion Criteria (General):
- Possible secondary causes of dementia, concomitant or history of neurological or psychiatric illness (other than stroke or Parkinsonism)
- History of alcohol or substance abuse or dependence within the past 2 years
- Normal Control Inclusion Criteria:
- Age between 40-90
- Fluent in English
- Completed 8 years of education or higher
- No significant memory complaints
- Normal Control Exclusion Criteria:
- Being treated or history of being treated for psychiatric or neurological illness
- History of alcohol or substance abuse or dependence within the past 2 years
- Current use of psychoactive medications (e.g. antidepressant, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.)
- Medical contraindications to MRI
Age in the registry: 40 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.