About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Possible or probable diagnosis of MCI or early dementia
Age 30-95
Study partner who has some weekly contact with patient. Some of the neuropsychological assessment require collateral from close contacts to assess cognition and functioning. Since neurodegenerative diseases can be associated with reduced cognition, including reduced awareness of one's own impairments, participants will be assessed for their capacity to consent at all study visits.
Must, in the opinion of the site investigator, be able to complete most study procedures.
Disqualifiers
Participants who are not able to complete the majority of assessments in the opinion of the PI are excluded from the study. Exclusion criteria are evaluated at the site investigator's discretion; if the site investigator believes that the participant's symptoms are due to causes other than neurodegeneration, despite the presence of an exclusionary condition, the investigator may overrule the exclusion.
Trial population
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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Cognitive phenotype
Change in Toronto Cognitive Assessment (TorCA) scores out of 330, where lower scores indicate increasing cognitive impairments, and individual domains.
Secondary outcomes
Assessment of DNA methylation (DNAm) from bloodwork
Biological age from DNA methylation (DNAm) collected via bloodwork compared to chronological age.
Neurodegenerative protein levels in biofluids and skin biopsy
Differences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Baycrest
Collaborator
Centre for Addiction and Mental Health
Collaborator
Toronto Dementia Research Alliance (TDRA)
Collaborator
University of Toronto
Collaborator