Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling (CRND TorCA)

November 17, 2025 updated by: Carmela Tartaglia, University Health Network, Toronto
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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M6A 2E1
        • Not yet recruiting
        • Baycrest
        • Contact:
        • Sub-Investigator:
          • Morris Freedman, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Sub-Investigator:
          • Sandra E Black, MD
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital, University Health Network
        • Contact:
        • Principal Investigator:
          • Maria C Tartaglia, MD
      • Toronto, Ontario, Canada, M6J 1H1
        • Not yet recruiting
        • Centre for Addiction and Mental Health
        • Sub-Investigator:
          • Sanjeev Kumar, MD
        • Sub-Investigator:
          • Tarek Rajji, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive phenotype
Time Frame: Baseline, 6-month follow-up, 1-year follow-up
Change in Toronto Cognitive Assessment (TorCA) scores out of 330, where lower scores indicate increasing cognitive impairments, and individual domains.
Baseline, 6-month follow-up, 1-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodegenerative protein levels in biofluids and skin biopsy
Time Frame: Baseline, 6-month follow-up, 1-year follow-up
Differences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA
Baseline, 6-month follow-up, 1-year follow-up
Assessment of DNA methylation (DNAm) from bloodwork
Time Frame: Baseline
Biological age from DNA methylation (DNAm) collected via bloodwork compared to chronological age.
Baseline
Structural and Functional Differences between neurodegenerative diseases via MRI of the brain
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Sunnybrook Health Sciences Centre
Centre for Addiction and Mental Health
University of Toronto
Baycrest
Toronto Dementia Research Alliance (TDRA)

Investigators

  • Principal Investigator: Maria C Tartaglia, M.D., Toronto Western Hospital, UHN; Tanz CRND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers. Only anonymized responses to the cognitive assessment, clinical assessment, behavioural questionnaires and biofluid protein levels will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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