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

NCT06529744 | Recruiting

• 1 other identifier: 24-5283
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

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; Mild Cognitive Impairment; Corticobasal Syndrome; Progressive Supranuclear Palsy; Parkinson Disease; Primary Progressive Aphasia

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

Outcome Measures

Primary Outcomes (1)

• Cognitive phenotype

  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 Outcomes (3)

• Assessment of DNA methylation (DNAm) from bloodwork

  Baseline

• Neurodegenerative protein levels in biofluids and skin biopsy

  Baseline, 6-month follow-up, 1-year follow-up

• Structural and Functional Differences between neurodegenerative diseases via MRI of the brain

  Baseline

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Baycrest: collaborator
• Centre for Addiction and Mental Health: collaborator
• Toronto Dementia Research Alliance (TDRA): collaborator
• University of Toronto: collaborator

Study Sites (4)

Baycrest

North York, Ontario, M6A 2E1, Canada

NOT YET RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

NOT YET RECRUITING

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H1, Canada

NOT YET RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Blood (including plasma, serum, RNA, and DNA), skin biopsy, and cerebrospinal fluid.

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Frontotemporal Dementia; Cognitive Dysfunction; Corticobasal Degeneration; Supranuclear Palsy, Progressive; Parkinson Disease; Aphasia, Primary Progressive

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Study Officials

• Maria C Tartaglia, M.D.

  Toronto Western Hospital, UHN; Tanz CRND

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Clementi, HBSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: July 31, 2024
• Study Start: November 11, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)