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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01800214
First received: February 25, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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
Dementia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Group differences for each cognitive, imaging and biomarker measurement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 1200
Study Start Date: September 1995
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800214

Locations
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
Baycrest
Investigators
Principal Investigator: Sandra E Black, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Sandra E Black, Brill Chair in Neurology, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01800214     History of Changes
Other Study ID Numbers: CIHR MOP-13129, MOP-13129
Study First Received: February 25, 2013
Last Updated: August 12, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Sunnybrook Health Sciences Centre:
neurodengeneration
neuroimaging

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014