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DementiaSDSNCT01800214

The Sunnybrook Dementia Study

An observational study of Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Dementia
How many people
1,800 participants
Where
1 siteCanada
Study dates
Sep 1995to Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consisted of a sample of outpatients who attended a tertiary-care neurology clinic at the Sunnybrook Health Sciences Centre.

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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. Nearly 1800 patients (Mild Cognitive Impairment or dementia from AD, Vascular, Frontotemporal or Lewy Body Disease) and over 140 normal elderly have already been enrolled, with 180 autopsies.

Read more

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.

Conditions
Dementia
Keywords
neurodengeneration, neuroimaging
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01800214
Study groupRoleWhat they receive
Alzheimer's disease (AD)Not described
Vascular Cognitive Disorders (VCD)Not described
Lewy Body Disease (LBD)Not described
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)Not described
Cognitively Normal (CN)Not described
Small Vessel Disease -Neurodegenerative (SVD)Not described
Subjective Cognitive Complaints (SCC)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 years

Secondary outcomes (4)

  1. 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

    Measured: 5 years

  2. 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

    Measured: 5 years

  3. Group differences for each cognitive, imaging and biomarker measurement

    Measured: 5 years

  4. Clinico-pathologic correlations between autopsy-confirmed histopathology and clinical features including clincial diagnosis, regaional atrophy, regional hypoperfusion, and white matter interintensities on MRI

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2013 (estimated)
  2. Study startSep 1995
  3. Primary completionJul 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800214
Sponsor's protocol ID
CIHR MOP-13129
Other IDs
MOP-13129
Acronym
SDS
Status last verified
Feb 2026
First submitted
25 Feb 2013
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Raw data which is not identifiable and analyzed data (would have to do face stripping from DICOMs)

Publications

  • 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.

    PubMed 37989710

  • 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.

    PubMed 34784815

  • 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.

    PubMed 30185213

  • 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.

    PubMed 29782824

  • 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.

    PubMed 29374101

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01800214, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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