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The Sunnybrook Dementia Study

Prospective Neuroimaging, Cognition and Behavioural Study of Alzheimer's, Vascular, Parkinson's, Frontotemporal and Mixed Dementias

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01800214
Acronym
SDS
Enrollment
1800
Registered
2013-02-27
Start date
1995-09-01
Completion date
2026-09-01
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

neurodengeneration, neuroimaging

Brief summary

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.

Interventions

None listed

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER
University of Toronto
CollaboratorOTHER
Sunnybrook Research Institute
CollaboratorOTHER
University of Waterloo
CollaboratorOTHER
Baycrest
CollaboratorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Volumetric change in brain structures and brain lesions on Magnetic Resonance Imaging (MRI) across the dementias covarying for age, sex, education and Apolipoprotein E (ApoE) status5 yearsBrain structures including whole brain, hippocampus, tissue volumes and cortical thickness in predefined regions of interest; brain lesions including lacunes, subcortical white matter hyperintensities, and stroke

Secondary

MeasureTime frame
Rate of clinical decline as measured by detailed conventional neuropsychological testing, instrumental and standard activities of daily living assessments, caregiver forms, and behavioral psychiatric inventories5 years
Rate of change in perfusion patterns measured on Single Photon Emission Computerized Tomography (SPECT) at baseline and followup contrasts on a voxel-wise basis using Statistical Parametric Mapping (SPM), or in 79 predefined regions of interest5 years
Group differences for each cognitive, imaging and biomarker measurement5 years
Clinico-pathologic correlations between autopsy-confirmed histopathology and clinical features including clincial diagnosis, regaional atrophy, regional hypoperfusion, and white matter interintensities on MRI5 years

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORSandra E Black, MD

Sunnybrook Health Sciences Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026