Predicting disease progression in dementia using biomarkers and modeling
Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling
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 type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 30 Years to 95 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 4 sites (North York, Ontario and 3 other locations) |
| Trial ID | NCT06529744 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using biomarkers and integrative modeling for predicting dementia progression, suggesting that this approach has potential for success.
Eligibility criteria
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 this trial is running
North York, Ontario and 3 other locations
- Baycrest — North York, Ontario, Canada (Not_yet_recruiting)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.