This trial is active, not recruiting.

Condition dementia
Sponsor Sunnybrook Health Sciences Centre
Collaborator University of Toronto
Start date September 1995
End date September 2015
Trial size 1200 participants
Trial identifier NCT01800214, CIHR MOP-13129, MOP-13129


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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)

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 90 years old.

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

Additional Information

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
Principal investigator Sandra E Black, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre.