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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-95
SponsorUniversity Health Network, Toronto

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Assessment of DNA methylation (DNAm) from bloodwork

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

Time frame
Baseline
2

Neurodegenerative protein levels in biofluids and skin biopsy

Differences in protein levels between neurodegenerative diagnoses and predictive ability for change in TorCA

Time frame
Baseline, 6-month follow-up, 1-year follow-up
3

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

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Sunnybrook Health Sciences Centre

Collaborator

Baycrest

Collaborator

Centre for Addiction and Mental Health

Collaborator

Toronto Dementia Research Alliance (TDRA)

Collaborator

University of Toronto

Collaborator