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The Sunnybrook Dementia Study (SDS)

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ClinicalTrials.gov Identifier: NCT01800214
Recruitment Status : Recruiting
First Posted : February 27, 2013
Last Update Posted : March 22, 2021
Sponsor:
Collaborators:
University of Toronto
Sunnybrook Research Institute
University of Waterloo
Baycrest
Information provided by (Responsible Party):
Dr. Sandra E Black, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date February 25, 2013
First Posted Date February 27, 2013
Last Update Posted Date March 22, 2021
Study Start Date September 1995
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 26, 2013)
  • 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 ]
  • 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 ]
  • Group differences for each cognitive, imaging and biomarker measurement [ Time Frame: 5 years ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: February 25, 2013)
  • 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 ]
  • 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 ]
  • Group differences using multimodal structural imaging and perfusion measures, in correlation with clinical measures [ Time Frame: 5 years ]
  • Correlations between pathology and diagnostic accuracy; clinical, structural and perfusion imaging measures [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Sunnybrook Dementia Study
Official Title Prospective Neuroimaging, Cognition and Behavioural Study of Alzheimer's, Vascular, Parkinson's, Frontotemporal and Mixed Dementias
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Whole blood

Retention: Samples with microbiome

Description:

Fecal Sample

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.
Condition Dementia
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 20, 2020)
1300
Original Estimated Enrollment
 (submitted: February 25, 2013)
1200
Estimated Study Completion Date September 2025
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility 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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Morgan Koo, BScH. 416-480-6100 ext 83757 morgan.koo@sunnybrook.ca
Contact: Christopher Scott, MSc. 416-480-6100 ext 83792 christopher.scott@sunnybrook.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01800214
Other Study ID Numbers CIHR MOP-13129
MOP-13129 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dr. Sandra E Black, Sunnybrook Health Sciences Centre
Study Sponsor Sunnybrook Health Sciences Centre
Collaborators
  • University of Toronto
  • Sunnybrook Research Institute
  • University of Waterloo
  • Baycrest
Investigators
Principal Investigator: Sandra E Black, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date March 2021