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NCT Number: NCT06529744

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

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).

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Key information

Conditions

Dementia Alzheimer Disease Aphasia Aphasia, Primary Progressive Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Communication Disorders Corticobasal Degeneration Corticobasal Syndrome Cranial Nerve Diseases Dementia With Lewy Bodies Dementia, Vascular Eye Diseases Frontotemporal Dementia Frontotemporal Lobar Degeneration Intracranial Arterial Diseases Intracranial Arteriosclerosis Language Disorders Leukoencephalopathies Lewy Body Disease Mental Disorders Metabolic Diseases Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Primary Progressive Aphasia Progressive Supranuclear Palsy Proteostasis Deficiencies Signs and Symptoms Speech Disorders Supranuclear Palsy, Progressive Synucleinopathies TDP-43 Proteinopathies Tauopathies Vascular Dementia Vascular Diseases

Age range

30 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baycrest, North York, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assessment of DNA methylation (DNAm) from bloodwork

    Time frame: Baseline

    Biological age from DNA methylation (DNAm) collected via bloodwork compared to chronological age.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Clementi, HBSc

CONTACT

[email protected]

416-603-5914

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

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

Registry information

Acronym: CRND TorCA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 31, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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