Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT05124392

Biomarker Profiling in Individuals at Risk for Prion Disease

Led by Massachusetts General Hospital · Updated on 2026-04-22

150

Participants Needed

1

Research Sites

495 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

B

Broad Institute of MIT and Harvard

Collaborating Sponsor

AI-Summary

What this Trial Is About

We are doing this research to identify biomarkers in individuals who are at-risk for familial prion disease. We hope to use these biomarkers to predict timing of disease onset in pre-symptomatic individuals and to guide the direction of future clinical trials.

CONDITIONS

Official Title

Biomarker Profiling in Individuals at Risk for Prion Disease

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 85 years
  • Known carrier of pathogenic PRNP mutation, or
  • History of probable or definite prion disease in biological parent and other family members, or
  • Non-carrier family members and/or unrelated previously enrolled negative control volunteers
  • Medically safe to undergo blood draw, lumbar puncture, and cognitive testing
  • Adequate visual and auditory ability to complete cognitive testing
  • Fluent in English
  • At least 5 years of education
  • Capable of providing informed consent and following study procedures
  • No contraindications to MRI scanning for PRNP mutation carriers as determined by MRI screening
Not Eligible

You will not qualify if you...

  • Any central nervous system disease other than asymptomatic or early prion disease, including stroke, brain tumor, multiple sclerosis, significant head trauma with lasting neurological or cognitive deficits, Alzheimer's disease, Parkinson's disease, frontotemporal lobar degeneration, or other known neurodegenerative diseases
  • History of alcohol or other substance abuse or dependence within the past two years
  • Any significant systemic illness, unstable medical condition, or pregnancy posing safety risk or affecting study participation
  • Coagulopathy or use of anti-coagulant therapy increasing risk for blood draw or lumbar puncture, with PT/PTT and INR results over 1.5 standard deviations above upper normal limits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Alzheimer's Clinical and Translational Research Unit

Charlestown, Massachusetts, United States, 02129

Actively Recruiting

Loading map...

Research Team

S

Sophia D'Alessandro

CONTACT

A

Alison McManus, DNP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Biomarker Profiling in Individuals at Risk for Prion Disease | DecenTrialz