Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07840547

Conditions

Creutzfeldt-Jakob Disease (CJD) | Prion Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Teleneurology Assessment

Study Details

Brief summary:

This observational study uses secure videoconference visits to follow people with Creuztzfeldt-Jakob disease (CJD) over time. The study collects information about participants' symptoms, neurological function, thinking and memory, and ability to perform daily activities. It also collects information from study partners about the participant and about their own well-being and experiences as caregivers. The goal of the study is to better understand how CJD changes over time and to evaluate the use of remote assessments for CJD research and surveillance.

Conditions

Creutzfeldt-Jakob Disease (CJD) | Prion Disease

Study ID

NCT07840547

Start date

Jan 25, 2022

Status verified date

Sep, 2026

Completion date

Jan 25, 2032

Anticipated

Primary completion date

Jan, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Study Participant Inclusion Criteria:
  • Age greater than 18 years.
  • Participant must have a study partner who will be present with the participant for all videoconference evaluations (in the same physical location).
  • Participant meets criteria for definite or probable prion disease or is a known PRNP mutation carrier with active disease.
  • Participant and/or appropriate proxy consents to study participation.

Study Partner Inclusion Criteria:

  • Age greater than 18 years.
  • Study partner must be present with the participant for all videoconference evaluations and must have knowledge of the participant's abilities before the onset of illness. The study partner should be with the participant at least three times per week or for a total of five hours per week as the illness progresses.
  • Study partner must have internet access and a computer, smartphone, or tablet with videoconference capabilities.
  • Study partner consents to study participation.

Exclusion Criteria:

Study Participant Exclusion Criteria:

  • Participant's diagnosis is most likely not prion disease.
  • Participant or study partner is less than 18 years of age.
  • Participant or study partner does not have internet access or a computer, smartphone, or tablet with videoconference capabilities.
  • Participant does not have a study partner.

Study Partner Exclusion Criteria:

  • Study partner is less than 18 years of age.
  • Study partner does not have sufficient knowledge of the participant's abilities prior to the onset of illness or does not have sufficient ongoing contact with the participant.
  • Study partner does not have internet access or a computer, smartphone, or tablet with videoconference capabilities.
  • Study partner does not consent to study participation.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Prion Disease

Adults with definite or probable prion disease, or known PRNP mutation carriers with active disease, who participate in longitudinal videoconference assessments with a study partner.

Interventions

Teleneurology Assessment

Participants undergo standardized videoconference-based assessments of clinical history, cognitive function, neurological function, functional status, and neuropsychiatric symptoms. Study partners provide information about the participant and complete caregiver well-being and burden assessments.

Primary outcome measure

  • Number of Participants who complete a Teleneurology Assessment [ Time Frame: Baseline through end of participant follow-up, up to 10 years. ]

Central Contacts and Locations

Central contacts

Brian S Appleby, MD

216-368-0587cjdsurveillance@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Brian S Appleby, MD

216-368-0587cjdsurveillance@uhhospitals.org

Katie Glisic

216-368-0587

Principal Investigator:

Brian S Appleby, M.D.

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • CJD
  • Creutzfeldt-Jakob Disease
  • Prion Disease
  • Teleneurology
  • Telemedicine
  • Natural History
  • Caregiver Burden
  • CJD Surveillance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.