CLIME-CJD multimodal retrospective CJD cohort (NCT07589283)

CLIME-CJD is a single-centre, retrospective, record-based cohort registered on ClinicalTrials.gov by the First Affiliated Hospital of Fujian Medical University in Fuzhou, China. It looks back over routine records of patients with definite or probable CJD seen between 2022 and 2031 and counts how often the expected findings appear in five domains: clinical symptoms, blood markers, CSF 14-3-3 and RT-QuIC, MRI and EEG. No new tests or treatments are involved. It adds little new method but is a useful real-world data point on how classic and newer CJD tests perform in a Chinese hospital.

Status as of 2026-11-01. Please check the study registry for the latest position.

Key facts

  • The sponsor and responsible party is the First Affiliated Hospital of Fujian Medical University; no collaborators are listed.
  • The design is observational, a retrospective cohort and patient registry, with no interventions, and data come only from existing medical records.
  • Estimated enrolment is 150 participants; the status is enrolling by invitation, verified May 2026.
  • The study start is recorded as 1 January 2022 (actual) with primary and study completion estimated for December 2031.
  • Eligibility requires definite or probable CJD by WHO criteria and at least some clinical, blood, CSF, MRI or EEG records; patients are found through electronic record diagnostic codes.
  • The primary outcome is the share of patients with characteristic findings in five domains: symptoms, peripheral blood markers, CSF 14-3-3 and RT-QuIC, MRI (cortical ribboning or basal ganglia hyperintensity) and EEG (periodic sharp wave complexes).
  • The registry lists one site (Fuzhou), no contacts, no results posted and no sharing of individual participant data.
  • The same department published a retrospective cohort of 37 probable or very probable sCJD patients hospitalised 2020 to 2024 using the Chinese CJD Diagnosis Guidelines 2021; typical periodic sharp wave complexes were seen in 83.8 percent and CSF 14-3-3 was positive in 24 of 30 tested (80 percent).
  • That 2025 paper reported no neuropathological confirmation, no PRNP or subtype data, and did not report RT-QuIC or blood markers.
  • A 2024 systematic review from Fujian Medical University authors, covering sCJD in people aged 80 and over (15 cases), gave small-sample CSF sensitivities of 83.3 percent for total tau, 75.0 percent for 14-3-3 and 75.0 percent for RT-QuIC.

Timeline

  1. 2022Study period start recorded in the registry (actual).
  2. 2024Fujian Medical University authors publish the systematic review of sCJD in people aged 80 and over.
  3. 2025He and Qiu publish the 37-patient hospital cohort (patients hospitalised 2020 to 2024).
  4. 2026Registry record first posted; first submitted 2026-05-06.
  5. 2026Latest record version seen by this worker.
  6. 2031Estimated primary and study completion.

Last checked 1 November 2026

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