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

Recruiting

• Conditions: Dementia; Alzheimer Disease; Dementia with Lewy Bodies; Vascular Dementia; Frontotemporal Dementia; Mild Cognitive Impairment; Corticobasal Syndrome; Progressive Supranuclear Palsy; Parkinson Disease; Primary Progressive Aphasia

• Registration Number: NCT06529744
• Lead Sponsor: University Health Network, Toronto

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-11-11
• Study First Submitted: 2024-04-29
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-31
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Referring diagnosis of MCI or early dementia
• Age 40-95
• 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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive phenotype	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.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada

Baycrest; 🇨🇦 North York, Ontario, Canada