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

NCT ID: NCT06529744

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2027-11-30

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Baycrest

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

Toronto Dementia Research Alliance (TDRA)

UNKNOWN

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Carmela Tartaglia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria C Tartaglia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hospital, UHN; Tanz CRND

Locations

Baycrest

North York, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Claudia Clementi, HBSc

Role: CONTACT

claudia.clementi@uhn.ca

416-603-5914

Facility Contacts

Aymin Mumtaz

Role: primary

amumtaz@research.baycrest.org

416-785-2500 ext. 6324

Ljubica Zotovic

Role: primary

ljubica.zotovic@sunnybrook.ca

416-480-6100 ext. 3004

Claudia Clementi

Role: primary

claudia.clementi@uhn.ca

416-603-5914

Loreque Fearon, BASc

Role: primary

Loreque.Fearon@camh.ca

416-535-8501 ext. 39589

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Other Identifiers

24-5283

Identifier Type: -

Identifier Source: org_study_id