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P021

Peptide 021, GLXC-21260

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Studies 37
Trials 57
Not Yet Recruiting OBSERVATIONAL NCT07168447

Transfusion Exchanges and Cognition in Sickle Cell Disease

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

DREPA-COG is an observational study evaluating the effect of exchange transfusions on cognitive function in adults with severe sickle cell disease (SS or Sβ0). Information processing speed is assessed at three time points during the transfusion cycle using the Symbol Digit Modalities Test (SDMT) and additional validated neuropsychological measures. This minimal-risk, fully remote study aims to identify processing speed as a reproducible marker for clinical monitoring and future therapeutic trials.

Detailed Description

DREPA-COG is a non-interventional, multicenter observational study investigating the effect of exchange transfusions on cognitive performance in adults with severe sickle cell disease (SS or Sβ0). Cognitive complications, including slowed information processing and executive dysfunction, are frequent and disabling in this population. Exchange transfusion, a standard therapy replacing sickled red blood cells with donor cells, may positively influence cognition, but systematic evidence is lacking. The study evaluates information processing speed as a potential neurological marker across the transfusion cycle. Participants complete three brief neuropsychological assessments remotely by videoconference: before the transfusion, one week after, and prior to the next transfusion. The Symbol Digit Modalities Test (SDMT) is the primary measure, complemented by validated assessments of global cognition, attention, memory, fatigue, mood, and pain. Primary analysis will use mixed-effects models to assess changes in processing speed over time, adjusting for demographic and clinical covariates. This minimal-risk, fully remote study requires no additional hospital visits and aims to establish processing speed as a reproducible and clinically relevant outcome measure in sickle cell disease.

Primary Outcomes

Measure: Information Processing Speed
TimeFrame: 48 hours before the transfusion exchange
Description: Primary outcome measure: Information processing speed, assessed using the oral version of the Symbol Digit Modality Test (SDMT), as a marker of cerebral involvement in adult patients with sickle cell disease.
Measure: Information Processing Speed
TimeFrame: 7 to 9 days after the transfusion exchange
Description: Primary outcome measure: Information processing speed, assessed using the oral version of the Symbol Digit Modality Test (SDMT), as a marker of cerebral involvement in adult patients with sickle cell disease.
Measure: Information Processing Speed
TimeFrame: within 48 hours before the next scheduled transfusion exchange
Description: Primary outcome measure: Information processing speed, assessed using the oral version of the Symbol Digit Modality Test (SDMT), as a marker of cerebral involvement in adult patients with sickle cell disease.

Trial Information

NCT ID

NCT07168447

Status

Not Yet Recruiting

Study Type

OBSERVATIONAL

Sponsor

Centre Hospitalier St Anne

Last Updated

December 15, 2025