NCT05124392 OBSERVE: Biomarkers in Individuals at Risk for Prion Disease
| NCT ID | NCT05124392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | CJD (Creutzfeldt Jakob Disease) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2017-12-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2017-12-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 - 85, 2. One of the following: * a. Known carrier of pathogenic PRNP mutation * b. History of probable or definite prion disease in biological parent and other family members * c. Non-carrier family members and/or unrelated previously enrolled negative control volunteers 3. Medically safe to undergo blood draw, lumbar puncture and cognitive testing, 4. Adequate visual and auditory acuity to complete cognitive testing, 5. Fluent in English, 6. At least 5 years of education, 7. Capable of providing informed consent and following study procedures, Exclusion Criteria: 1. Any CNS disease other than asymptomatic or early prion disease, such as clinical stroke, brain tumor, multiple sclerosis, significant head trauma with persistent neurological or neurocognitive deficits, Alzheimer's disease, Parkinson's disease, frontotemporal lobar degeneration or other known neurodegenerative disease, 2. History of alcohol or other substance abuse or dependence within the past two years, 3. Any significant systemic illness or unstable medical condition or pregnancy that could represent safety risk or affect participation in the study, 4. Coagulopathy or anti-coagulant therapy (such as Coumadin) increasing the risk for phlebotomy or lumbar puncture resulting in PT/PTT and INR within 1.5 standard deviation over the upper normal limit.
Contact & Investigator
Steven E Arnold, MD
PRINCIPAL INVESTIGATOR
MGH
Frequently Asked Questions
Who can join the NCT05124392 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying CJD (Creutzfeldt Jakob Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05124392 currently recruiting?
Yes, NCT05124392 is actively recruiting participants. Contact the research team at MGHPrionStudy@partners.org for enrollment information.
Where is the NCT05124392 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT05124392 clinical trial?
NCT05124392 is sponsored by Massachusetts General Hospital. The principal investigator is Steven E Arnold, MD at MGH. The trial plans to enroll 150 participants.