An observational study in Dementia, Alzheimer Disease and Dementia With Lewy Bodies, sponsored by University Health Network, Toronto. Recruiting at 4 sites in Canada. Open to participants aged 30 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by University Health Network, Toronto · Observational
To develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).
The goal of this study is to create a model to predict disease progression in patients with mild cognitive impairments and forms of dementia. To accomplish this, the current study will evaluate different tests including: brain imaging (MRI), body fluid samples (blood and cerebrospinal fluid), skin biopsy, cognitive ability, and behavioural questionnaires. The study team hopes that this information can be used to guide diagnosis and better predict disease progression in patients with mild cognitive impairment and and early dementia.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 500 is above the median of 250 across 482 observational studies indexed under Dementia.
Browse Dementia studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals who have been diagnosed with a mild cognitive impairment or early stage dementia that are between the ages of 30-95 can participate in the study as long as they have a study partner who can answer questionnaires at their 3 study visits and can complete a majority of assessments.
Exclusion Criteria:
Cognitive phenotype
Change in Toronto Cognitive Assessment (TorCA) scores out of 330, where lower scores indicate increasing cognitive impairments, and individual domains.
Time frame: Baseline, 6-month follow-up, 1-year follow-up
Assessment of DNA methylation (DNAm) from bloodwork
Biological age from DNA methylation (DNAm) collected via bloodwork compared to chronological age.
Time frame: Baseline
Neurodegenerative protein levels in biofluids and skin biopsy
Differences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA
Time frame: Baseline, 6-month follow-up, 1-year follow-up
Structural and Functional Differences between neurodegenerative diseases via MRI of the brain
Brain volumes and white matter hyperintensity (WMH) load corresponding to Toronto Cognitive Assessment (TorCA) scores out of 330 where lower scores indicate increasing cognitive impairments.
Time frame: Baseline
Plan to share: No — Individual participant data will not be available to other researchers. Only anonymized responses to the cognitive assessment, clinical assessment, behavioural questionnaires and biofluid protein levels will be shared.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Health Network, Toronto