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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06529744
Acronym
CRND TorCA
Enrollment
500
Registered
2024-07-31
Start date
2023-11-11
Completion date
2027-11-30
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Corticobasal Syndrome, Dementia, Dementia With Lewy Bodies, Frontotemporal Dementia, Mild Cognitive Impairment, Parkinson Disease, Primary Progressive Aphasia, Progressive Supranuclear Palsy, Vascular Dementia

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

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).

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.

Interventions

None listed

Sponsors

Sunnybrook Health Sciences Centre
CollaboratorOTHER
Baycrest
CollaboratorOTHER
Centre for Addiction and Mental Health
CollaboratorOTHER
Toronto Dementia Research Alliance (TDRA)
CollaboratorUNKNOWN
University of Toronto
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 95 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive phenotypeBaseline, 6-month follow-up, 1-year follow-upChange in Toronto Cognitive Assessment (TorCA) scores out of 330, where lower scores indicate increasing cognitive impairments, and individual domains.

Secondary

MeasureTime frameDescription
Assessment of DNA methylation (DNAm) from bloodworkBaselineBiological age from DNA methylation (DNAm) collected via bloodwork compared to chronological age.
Neurodegenerative protein levels in biofluids and skin biopsyBaseline, 6-month follow-up, 1-year follow-upDifferences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA
Structural and Functional Differences between neurodegenerative diseases via MRI of the brainBaselineBrain volumes and white matter hyperintensity (WMH) load corresponding to Toronto Cognitive Assessment (TorCA) scores out of 330 where lower scores indicate increasing cognitive impairments.

Countries

Canada

Contacts

Primary ContactClaudia Clementi, HBSc
claudia.clementi@uhn.ca416-603-5914

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026