Creutzfeldt-Jakob Disease (CJD) | Prion DiseaseTAPCJDNCT07840547
Teleneurology Assessment Program for Creutzfeldt-Jakob Disease
An observational study of Creutzfeldt-Jakob Disease (CJD) | Prion Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Creutzfeldt-Jakob Disease (CJD) | Prion Disease
- What is being tested?
- Teleneurology Assessment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 25 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with definite or probable prion disease, or known PRNP mutation carriers with active disease, who are referred to TAPCJD and meet study eligibility criteria. Each participant must have an adult study partner who knows the participant well, has regular contact with them, and is present for the videoconference assessments.
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Brian S Appleby, MD, 216-368-0587, cjdsurveillance@uhhospitals.org
Katie Glisic, 216-368-0587
About this study
Official title: Expanded Protocol for Teleneurology Assessment Program for Creutzfeldt-Jakob Disease (TAPCJD)
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.
Read the detailed description
TAPCJD is a longitudinal observational study designed to collect standardized clinical information from individuals with Prion Disease using remote videoconference assessments. The study builds upon an earlier TAPCJD pilot study and is intended to improve understanding of the clinical course of Prion Disease and the use of remote assessments in prion disease research and surveillance.
Participants take part in videoconference visits with a study partner who knows them well. Assessments include clinical history, cognitive assessment, modified neurological examination, functional assessment, and evaluation of neuropsychiatric symptoms. Study partners also complete measures related to caregiver well-being and burden.
Videoconference evaluations occur at baseline and at approximately 1, 2, 4, and 6 months, followed by evaluations every three months for the duration of the participant's survival. Assessments may be modified or omitted depending on the participant's clinical condition. Participation ends at death, if the clinical diagnosis changes and no longer includes prion disease, or if the participant or study partner chooses to discontinue participation.
The study also examines the reliability and validity of standardized remote assessments, caregiver burden and well-being, and the potential benefits of caregiver support-group participation.
- Being tested
- Teleneurology Assessment
- Keywords
- CJD, Creutzfeldt-Jakob Disease, Prion Disease, Teleneurology, Telemedicine, Natural History, Caregiver Burden, CJD Surveillance
- Medical subject headings
- Creutzfeldt-Jakob Syndrome, Prion Diseases, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleneurology AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Teleneurology Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who complete a Teleneurology Assessment
The number of participants who complete at least on standardized teleneurology assessment by videoconference will be recorded
Measured: Baseline through end of participant follow-up, up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start25 Jan 2022
- Primary completionJan 2032 (estimated)
- Study completion25 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Creutzfeldt-Jakob Disease (CJD) | Prion DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, CJD Foundation
- Responsible party
- Principal investigator, Brian Appleby, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840547
- Sponsor's protocol ID
- STUDY20211632
- Acronym
- TAPCJD
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data may be shared.
Publications
Kovacevich A, Martin JT, Glisic K, Ogrocki P, Appleby BS. Caregiver Burden in Prion Disease. Dement Geriatr Cogn Dis Extra. 2025 Nov 24;16(1):4-10. doi: 10.1159/000549584. eCollection 2026 Jan-Dec.
PubMed 41510146Leidy L, Yarlas A, Pulido RS, Ludwig J, Glisic K, Appleby BS. Internal consistency, construct validity, and responsiveness of the MRC Prion Disease Rating Scale. J Patient Rep Outcomes. 2025 May 6;9(1):49. doi: 10.1186/s41687-025-00884-3.
PubMed 40327161Appleby BS, Glisic K, Rhoads DD, Bizzi A, Cohen ML, Mahajan S. Feasibility of Remote Assessment of Human Prion Diseases for Research and Surveillance. Dement Geriatr Cogn Disord. 2019;47(1-2):79-90. doi: 10.1159/000497055. Epub 2019 Mar 12.
PubMed 30861521
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Protocol for Teleneurology Assessment Program for Creutzfeldt-Jakob Disease (TAPCJD)
- ClinicalTrials.gov ID
- NCT07840547
- Acronym / sponsor ID
- TAPCJD / STUDY20211632
- Keywords
- CJD, Creutzfeldt-Jakob Disease, Prion Disease, Teleneurology, Telemedicine, Natural History, Caregiver Burden, CJD Surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, CJD Foundation
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- 25 Jan 2032 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TAPCJD is a longitudinal observational study designed to collect standardized clinical information from individuals with Prion Disease using remote videoconference assessments. The study builds upon an earlier TAPCJD pilot study and is intended to improve understanding of the clinical course of Prion Disease and the use of remote assessments in prion disease research and surveillance.
Participants take part in videoconference visits with a study partner who knows them well. Assessments include clinical history, cognitive assessment, modified neurological examination, functional assessment, and evaluation of neuropsychiatric symptoms. Study partners also complete measures related to caregiver well-being and burden.
Videoconference evaluations occur at baseline and at approximately 1, 2, 4, and 6 months, followed by evaluations every three months for the duration of the participant's survival. Assessments may be modified or omitted depending on the participant's clinical condition. Participation ends at death, if the clinical diagnosis changes and no longer includes prion disease, or if the participant or study partner chooses to discontinue participation.
The study also examines the reliability and validity of standardized remote assessments, caregiver burden and well-being, and the potential benefits of caregiver support-group participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prion Disease | – | Other: Teleneurology AssessmentAdults with definite or probable prion disease, or known PRNP mutation carriers with active disease, who participate in longitudinal videoconference assessments with a study partner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with definite or probable prion disease, or known PRNP mutation carriers with active disease, who are referred to TAPCJD and meet study eligibility criteria. Each participant must have an adult study partner who knows the participant well, has regular contact with them, and is present for the videoconference assessments.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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 is less than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teleneurology AssessmentParticipants 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. | Other | Prion Disease |
Primary outcome
Number of Participants who complete a Teleneurology Assessment
Time frame: Baseline through end of participant follow-up, up to 10 years.
The number of participants who complete at least on standardized teleneurology assessment by videoconference will be recorded
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 41510146Kovacevich A, Martin JT, Glisic K, Ogrocki P, Appleby BS. Caregiver Burden in Prion Disease. Dement Geriatr Cogn Dis Extra. 2025 Nov 24;16(1):4-10. doi: 10.1159/000549584. eCollection 2026 Jan-Dec.
- Background: PubMed 40327161Leidy L, Yarlas A, Pulido RS, Ludwig J, Glisic K, Appleby BS. Internal consistency, construct validity, and responsiveness of the MRC Prion Disease Rating Scale. J Patient Rep Outcomes. 2025 May 6;9(1):49. doi: 10.1186/s41687-025-00884-3.
- Background: PubMed 30861521Appleby BS, Glisic K, Rhoads DD, Bizzi A, Cohen ML, Mahajan S. Feasibility of Remote Assessment of Human Prion Diseases for Research and Surveillance. Dement Geriatr Cogn Disord. 2019;47(1-2):79-90. doi: 10.1159/000497055. Epub 2019 Mar 12.
- Individual participant dataSharing planned: Yes. Deidentified participant data may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Creutzfeldt-Jakob Disease (CJD) | Prion Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian S Appleby, MD (216-368-0587, cjdsurveillance@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who complete a Teleneurology Assessment (time frame: Baseline through end of participant follow-up, up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07840547, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.