Actively Recruiting

Age: 30Years - 95Years
All Genders
ID06529744

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

Led by University Health Network, Toronto · Updated on 2025-11-20

500

Participants Needed

4

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

S

Sunnybrook Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are working to develop a model that can predict how diseases progress in patients with various neurodegenerative conditions, including Mild Cognitive Impairment (MCI) and different types of dementia such as Alzheimer's Disease, Lewy Body Disease, Vascular Dementia, and Frontotemporal Dementia. The study aims to improve diagnosis and forecasting of disease progression to better support patients with early dementia or cognitive impairment. The study will collect and evaluate several types of information from participants, including brain imaging with MRI, samples of blood and cerebrospinal fluid, skin biopsies, and assessments of cognitive ability and behavior through questionnaires. These tests will be done at baseline and during follow-up visits to gather detailed data on disease characteristics and progression. Participants will undergo evaluations at the start of the study, then again at 6 months and 1 year to monitor changes in cognition and other markers. The research team will analyze cognitive performance, DNA methylation from blood samples, neurodegenerative protein levels in fluids and skin, and brain structure and function via MRI. Participants will be monitored over time to provide data that may help predict how their condition changes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 30Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Possible or probable diagnosis of mild cognitive impairment or early dementia
  • Age between 30 and 95 years
  • Have a study partner who has regular weekly contact with the participant
  • Be able to complete most study procedures as judged by the site investigator
Not Eligible

You will not qualify if you...

  • Unable to complete the majority of assessments as judged by the site investigator
  • Symptoms believed to be caused by conditions other than neurodegeneration based on investigator's evaluation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessments

Participants undergo various tests including brain MRI, blood and cerebrospinal fluid sampling, skin biopsy, cognitive assessments, and behavioral questionnaires to evaluate their condition.

1 visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants are followed over time with repeated cognitive and biomarker assessments to monitor disease progression.

Visits at 6 months and 1 year (in-person)

Trial Site Locations

Total: 4 locations

1

Baycrest

North York, Ontario, Canada, M6A 2E1

Not Yet Recruiting

2

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Not Yet Recruiting

3

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

4

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1H1

Not Yet Recruiting

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Research Team

C

Claudia Clementi, HBSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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Published Research Related To This Trial

DNA methylation age-acceleration is associated with disease duration and age at onset in C9orf72 patients.

Ming Zhang, Maria Carmela Tartaglia, Danielle Moreno...

https://pubmed.ncbi.nlm.nih.gov/28439722