Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1800 participants
OBSERVATIONAL
1995-09-30
2025-09-30
Brief Summary
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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 1700 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.
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Alzheimer's disease (AD)
No interventions assigned to this group
Vascular Cognitive Disorders (VCD)
No interventions assigned to this group
Lewy Body Disease (LBD)
No interventions assigned to this group
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)
No interventions assigned to this group
Mild Cognitive Impairment (MCI)
No interventions assigned to this group
Cognitively Normal (CN)
No interventions assigned to this group
Small Vessel Disease -Neurodegenerative (SVD)
No interventions assigned to this group
Subjective Cognitive Complaints (SCC)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Age between 40-90
* Fluent in English
* Completed 8 years of education or higher
* No significant memory complaints
Exclusion Criteria
* History of alcohol or substance abuse or dependence within the past 2 years
* 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
40 Years
90 Years
ALL
Yes
Sponsors
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University of Toronto
OTHER
Sunnybrook Research Institute
OTHER
University of Waterloo
OTHER
Baycrest
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Sandra E Black
Brill Chair in Neurology
Principal Investigators
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Sandra E Black, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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References
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Callahan BL, Becker S, Ramirez J, Taylor R, Shammi P, Gao F, Black SE. Vascular Burden Moderates the Relationship Between ADHD and Cognition in Older Adults. Am J Geriatr Psychiatry. 2024 Apr;32(4):427-442. doi: 10.1016/j.jagp.2023.10.018. Epub 2023 Oct 30.
Callahan BL, Ramakrishnan N, Shammi P, Bierstone D, Taylor R, Ozzoude M, Goubran M, Stuss DT, Black SE. Cognitive and Neuroimaging Profiles of Older Adults With Attention Deficit/Hyperactivity Disorder Presenting to a Memory Clinic. J Atten Disord. 2022 Jun;26(8):1118-1129. doi: 10.1177/10870547211060546. Epub 2021 Nov 16.
Sapkota S, Ramirez J, Stuss DT, Masellis M, Black SE. Clinical dementia severity associated with ventricular size is differentially moderated by cognitive reserve in men and women. Alzheimers Res Ther. 2018 Sep 5;10(1):89. doi: 10.1186/s13195-018-0419-2.
Saeed U, Mirza SS, MacIntosh BJ, Herrmann N, Keith J, Ramirez J, Nestor SM, Yu Q, Knight J, Swardfager W, Potkin SG, Rogaeva E, St George-Hyslop P, Black SE, Masellis M. APOE-epsilon4 associates with hippocampal volume, learning, and memory across the spectrum of Alzheimer's disease and dementia with Lewy bodies. Alzheimers Dement. 2018 Sep;14(9):1137-1147. doi: 10.1016/j.jalz.2018.04.005. Epub 2018 May 18.
Swardfager W, Cogo-Moreira H, Masellis M, Ramirez J, Herrmann N, Edwards JD, Saleem M, Chan P, Yu D, Nestor SM, Scott CJM, Holmes MF, Sahlas DJ, Kiss A, Oh PI, Strother SC, Gao F, Stefanovic B, Keith J, Symons S, Swartz RH, Lanctot KL, Stuss DT, Black SE. The effect of white matter hyperintensities on verbal memory: Mediation by temporal lobe atrophy. Neurology. 2018 Feb 20;90(8):e673-e682. doi: 10.1212/WNL.0000000000004983. Epub 2018 Jan 26.
Other Identifiers
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MOP-13129
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CIHR MOP-13129
Identifier Type: -
Identifier Source: org_study_id
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