Clinical trial NCT06529744: Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling
Official title: Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling
Study type: OBSERVATIONAL
Overall status: 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
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Baycrest
name: Centre for Addiction and Mental Health
name: Toronto Dementia Research Alliance (TDRA)
name: University of Toronto
First posted: 2024-07-31
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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 40-95 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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Cognitive phenotype
timeFrame: Baseline, 6-month follow-up, 1-year follow-up
Secondary outcomes:
measure: Assessment of DNA methylation (DNAm) from bloodwork
timeFrame: Baseline
measure: Neurodegenerative protein levels in biofluids and skin biopsy
timeFrame: Baseline, 6-month follow-up, 1-year follow-up
measure: Structural and Functional Differences between neurodegenerative diseases via MRI of the brain
timeFrame: Baseline
Other outcomes:
Locations:
city: North York
country: Canada
facility: Baycrest
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Toronto Western Hospital, UHN; Tanz CRND
name: Maria C Tartaglia, M.D.
role: PRINCIPAL_INVESTIGATOR
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