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Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling

NCT06529744 · University Health Network, Toronto
In plain English

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About this study
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.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-11
Estimated completion: 2027-11
Last updated: 2025-11-20
Primary outcomes
  • Cognitive phenotype (Baseline, 6-month follow-up, 1-year follow-up)
Sponsor
University Health Network, Toronto · other
With: Sunnybrook Health Sciences Centre, Baycrest, Centre for Addiction and Mental Health, Toronto Dementia Research Alliance (TDRA), University of Toronto
Contacts & investigators
ContactClaudia Clementi, HBSc · contact · claudia.clementi@uhn.ca · 416-603-5914
InvestigatorMaria C Tartaglia, M.D. · principal_investigator, Toronto Western Hospital, UHN; Tanz CRND
All locations (4)
BaycrestNot Yet Recruiting
North York, Ontario, Canada
Sunnybrook Health Sciences CentreNot Yet Recruiting
Toronto, Ontario, Canada
Toronto Western Hospital, University Health NetworkRecruiting
Toronto, Ontario, Canada
Centre for Addiction and Mental HealthNot Yet Recruiting
Toronto, Ontario, Canada