RECRUITING

Biomarker Profiling in Individuals at Risk for Prion Disease

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Conditions

CJD (Creutzfeldt Jakob Disease)Prion DiseasesGSSFFIFamilial Fatal Insomnia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biomarker Profiling in Individuals at Risk for Prion Disease

Quick Facts

Study Start:2017-12-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05124392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 18 - 85,
  2. 2. One of the following:
  3. 1. Known carrier of pathogenic PRNP mutation
  4. 2. History of probable or definite prion disease in biological parent and other family members
  5. 3. Medically safe to undergo blood draw, lumbar puncture and cognitive testing,
  6. 4. Adequate visual and auditory acuity to complete cognitive testing,
  7. 5. Fluent in English,
  8. 6. At least 5 years of education,
  9. 7. Capable of providing informed consent and following study procedures.
  1. 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. 2. History of alcohol or other substance abuse or dependence within the past two years,
  3. 3. Any significant systemic illness or unstable medical condition or pregnancy that could represent safety risk or affect participation in the study,
  4. 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.

Contacts and Locations

Study Contact

Davi Soares
CONTACT
617-724-6094
dsoares3@mgh.harvard.edu
Jess Gerber
CONTACT
jgerber2@mgh.harvard.edu

Principal Investigator

Steven M Arnold, MD
PRINCIPAL_INVESTIGATOR
MGH

Study Locations (Sites)

Alzheimer's Clinical and Translational Research Unit
Charlestown, Massachusetts, 02129
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Steven M Arnold, MD, PRINCIPAL_INVESTIGATOR, MGH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-12-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2017-12-01
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • CJD (Creutzfeldt Jakob Disease)
  • Prion Diseases
  • GSS
  • FFI
  • Familial Fatal Insomnia