CLIME-CJD: A Multimodal Study

NCT07589283 | Enrolling By Invitation

• 1 other identifier: 2026-272-CLIME-CJD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Creutzfeldt-Jakob disease (CJD) is a rare and rapidly progressive neurological disorder. This study aims to describe and summarize the key features of CJD by looking back at medical records of patients who were diagnosed with CJD at our hospital. The researchers will collect information from routine clinical evaluations, including patients' symptoms, blood tests, cerebrospinal fluid analysis, brain imaging (such as MRI and PET), and electroencephalography (EEG). By analyzing these data together, the study hopes to provide a clearer picture of how CJD presents in routine clinical practice. This may help doctors recognize the disease more quickly in the future. No new tests or treatments will be given to patients. All data are collected from existing medical records.

Conditions

Creutzfeldt-Jakob Disease (CJD) | Prion Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of CJD Patients With Characteristic Diagnostic Findings

  The primary outcome is the proportion of patients showing characteristic abnormalities across five domains: clinical symptoms, peripheral blood markers, cerebrospinal fluid 14-3-3 protein and RT-QuIC, brain MRI (cortical ribboning or basal ganglia hyperintensity), and EEG (periodic sharp wave complexes).

  Baseline

Interventions

No Interventions OTHER

No Interventions

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population consists of patients who were diagnosed with Creutzfeldt-Jakob Disease (CJD) at the First Affiliated Hospital of Fujian Medical University between Jan 01, 2022 and Dec 31, 2031. Potential participants were identified through a search of the hospital's electronic medical record system using diagnostic codes for CJD and related prion diseases. All patients who met the inclusion and exclusion criteria and had sufficient medical record data available for abstraction were included in the analysis. No additional recruitment or active enrollment was performed, as this was a retrospective chart review study. The study population is expected to reflect the typical clinical presentation and diagnostic workup of CJD in a real-world hospital setting.

You may qualify if:

• Diagnosis of definite or probable Creutzfeldt-Jakob Disease (CJD) according to the established WHO diagnostic criteria
• Available medical records covering at least one of the following: clinical history, peripheral blood test results, cerebrospinal fluid (CSF) analysis findings, brain MRI reports/images, or EEG reports
• Hospitalized or evaluated at the participating institution during the study period

You may not qualify if:

• Alternative diagnosis confirmed that explains all clinical features (e.g., autoimmune encephalitis, rapidly progressive dementia due to other causes)
• Incomplete medical records with no relevant clinical, laboratory, imaging, or EEG data available
• Patient or legal representative declined the use of medical records for research purposes (where applicable according to local regulations)

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

MeSH Terms

Conditions

Creutzfeldt-Jakob Syndrome; Prion Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 15, 2026
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)