Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06529744

Conditions

Dementia

Alzheimer Disease

Dementia With Lewy Bodies

Vascular Dementia

Frontotemporal Dementia

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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).

Conditions

Dementia

Alzheimer Disease

Dementia With Lewy Bodies

Vascular Dementia

Frontotemporal Dementia

Study ID

NCT06529744

Start date

Nov 11, 2023

Status verified date

Nov, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Cognitive phenotype [ Time Frame: Baseline, 6-month follow-up, 1-year follow-up ]

Central Contacts and Locations

Central contacts

Claudia Clementi, HBSc

416-603-5914claudia.clementi@uhn.ca

Locations

Toronto Western Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Claudia Clementi

416-603-5914claudia.clementi@uhn.ca

Principal Investigator:

Maria C Tartaglia, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • alzheimer's disease
  • dementia
  • dementia with lewy bodies
  • vascular dementia
  • frontotemporal dementia
  • mild cognitive impairment
  • corticobasal syndrome
  • progressive supranuclear palsy
  • parkinson's disease
  • primary progressive aphasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-11-20.