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The Sunnybrook Dementia Study (SDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01800214
Recruitment Status : Recruiting
First Posted : February 27, 2013
Last Update Posted : May 17, 2022
University of Toronto
Sunnybrook Research Institute
University of Waterloo
Information provided by (Responsible Party):
Dr. Sandra E Black, Sunnybrook Health Sciences Centre

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. Over 1300 patients (Mild Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and 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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Prospective Neuroimaging, Cognition and Behavioural Study of Alzheimer's, Vascular, Parkinson's, Frontotemporal and Mixed Dementias
Study Start Date : September 1995
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Alzheimer's disease (AD)
Vascular Cognitive Disorders (VCD)
Lewy Body Disease (LBD)
Frontotemporal Dementia (FTD)
Behavioral-variant Frontotemporal Dementia (bvFTD) Language-variant Frontoemporal Dementia including Semantic dementia (SD) and Progressive non-fluent aphasia (PNFA) Corticobasal degeneration (CBD) Progressive supranuclear palsy (PSP)
Mild Cognitive Impairment (MCI)
Cognitively Normal (CN)
Small Vessel Disease -Neurodegenerative (SVD)
Subjective Cognitive Complaints (SCC)

Primary Outcome Measures :
  1. 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) status [ Time Frame: 5 years ]
    Brain 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 Outcome Measures :
  1. Rate of clinical decline as measured by detailed conventional neuropsychological testing, instrumental and standard activities of daily living assessments, caregiver forms, and behavioral psychiatric inventories [ Time Frame: 5 years ]
  2. 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 interest [ Time Frame: 5 years ]
  3. Group differences for each cognitive, imaging and biomarker measurement [ Time Frame: 5 years ]
  4. Clinico-pathologic correlations between autopsy-confirmed histopathology and clinical features including clincial diagnosis, regaional atrophy, regional hypoperfusion, and white matter interintensities on MRI [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

Whole blood

Retention: Samples with microbiome


Fecal Sample

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population consisted of a sample of outpatients who attended a tertiary-care neurology clinic at the Sunnybrook Health Sciences Centre.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01800214

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Contact: Morgan Koo, BScH. 416-480-6100 ext 83757
Contact: Christopher Scott, MSc. 416-480-6100 ext 83792

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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Toronto
Sunnybrook Research Institute
University of Waterloo
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Principal Investigator: Sandra E Black, MD Sunnybrook Health Sciences Centre
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Sandra E Black, Brill Chair in Neurology, Sunnybrook Health Sciences Centre Identifier: NCT01800214    
Other Study ID Numbers: CIHR MOP-13129
MOP-13129 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Sandra E Black, Sunnybrook Health Sciences Centre:
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders