The Sunnybrook Dementia Study

Dementia Clinical Trial

— SDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01800214
• Other study ID #: CIHR MOP-13129
• Secondary ID: MOP-13129
• Status: Recruiting
• Start date: September 1995
• Est. completion date: September 2025

Study information

• Verified date: June 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Morgan Koo, BScH.
• Phone: 416-480-6100
• Email: morgan.koo[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 1500 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Baycrest, Sunnybrook Research Institute, University of Toronto, University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5 years
Secondary	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		5 years
Secondary	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		5 years
Secondary	Group differences for each cognitive, imaging and biomarker measurement		5 years
Secondary	Clinico-pathologic correlations between autopsy-confirmed histopathology and clinical features including clincial diagnosis, regaional atrophy, regional hypoperfusion, and white matter interintensities on MRI		5 years

External Links

•   Study Info