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The Sunnybrook Dementia Study: Mapping Brain Changes in Alzheimer's, Vascular and Other Dementias

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. Read our disclaimer for details. Identifier: NCT01800214
Recruitment Status : Active, not recruiting
First Posted : February 27, 2013
Last Update Posted : September 30, 2019
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 1000 patients (Mild Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and 125 normal elderly have already been enrolled, with 150 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. 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 : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Vivo Brain Mapping in Cognitive Impairment From Alzheimer's, Vascular and Other Demenitas: A Longitudinal Brain-Behaviour Study With a Focus on Cerebrovascular Disease
Study Start Date : September 1995
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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)

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

Information from the National Library of Medicine

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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 six grades of education or higher
  • Visual and auditory acuity adequate for neuropsychological testing
  • Mini-Mental State Exam (MMSE) score > 10

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 50-90
  • Fluent in English
  • Completed six grades of education or higher
  • No significant memory complaints
  • Mini-Mental State Exam (MMSE) >24

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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Canada, Ontario
Sunnybrook Health Sciences Centre
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     History of Changes
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: September 30, 2019
Last Verified: September 2019
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