Clinical trial Recruiting at 1 site Observational Ages 30 to 95

Predicting disease progression in dementia using biomarkers and modeling

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

Run by University Health Network, Toronto · NCT06529744 · Data updated 2026-11-12

This study is trying to create a tool that helps predict how dementia will progress in people with mild cognitive impairment and different types of dementia, like Alzheimer's and Lewy Body Disease, by looking at brain scans, body fluids, and mental tests.

Quick facts

Study typeObservational
Ages30 Years to 95 Years
SexAll
Enrollment500 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations4 sites (North York, Ontario and 3 other locations)
StatusRecruiting
StartedNovember 11, 2023
Main results expectedNovember 2026
Study endsNovember 2027
Registry record updatedNovember 20, 2025
Trial IDNCT06529744 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged 40-95 who have been diagnosed with mild cognitive impairment or early dementia and have a study partner for support.

Probably not a fit

Patients who are unable to complete the majority of assessments or whose symptoms are attributed to non-neurodegenerative causes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop a predictive model for disease progression in patients with mild cognitive impairment and various forms of dementia, including Alzheimer's Disease and Lewy Body Disease. It will evaluate a range of assessments such as brain imaging, body fluid samples, and cognitive tests to gather comprehensive data. The goal is to utilize this information to enhance diagnostic accuracy and better forecast the progression of neurodegenerative diseases. By integrating multiple biomarkers and cognitive assessments, the study seeks to improve prognostic confidence in affected patients.

Why it matters

Potential benefit: If successful, this study could lead to more accurate predictions of disease progression, allowing for better patient management and treatment planning.

How similar studies have gone: Other studies have shown promise in using biomarkers and integrative modeling for predicting dementia progression, suggesting that this approach has potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Toronto Western Hospital, University Health Network
    Toronto, Ontario, Canada
    Recruiting
  • Baycrest
    North York, Ontario, Canada
    Not yet recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Not yet recruiting
  • Centre for Addiction and Mental Health
    Toronto, Ontario, Canada
    Not yet recruiting

Study contacts

  • Principal investigator: Maria C Tartaglia, M.D. — Toronto Western Hospital, UHN; Tanz CRND
  • Study coordinator: Claudia Clementi, HBSc
  • Email: claudia.clementi@uhn.ca
  • Phone: 416-603-5914

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.