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NCT05869669 (Neflamapimod in Dementia With Lewy Bodies): BVCT ex-ante prediction vs. reported outcome

On 19 Aug 2024, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 10 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05869669
Acronym
RewinD-LB
Drug Name
Neflamapimod
Drug MoA
p38alpha inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Dementia With Lewy Bodies
Human Patients
160
Sponsor
CervoMed
Phase
Phase 2

Prediction of , index 1762

Prospective Prediction
Prediction Index
1762
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in MSD-UPDRS3)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit in CDR-SB)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
113 days in advance
Readout Data Interpretation
neflamapimod failed to meet the primary efficacy endpoint CDR-SB; no data disclosed for MSD-UPDRS3
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Dementia With Lewy Bodies
Phase
Phase 2
Status
Completed
Enrollment
159
Lead sponsor
EIP Pharma Inc
Conditions
Dementia With Lewy Bodies
Interventions
DRUG: Neflamapimod; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-05-01
Primary completion
2025-05-29
Completion
2025-06-16
Results first posted
2026-09-03
Primary outcomes
  • Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) in Neflamapimod-treated Participants Compared to Placebo Recipients (Blinded Treatment Period) (16 weeks)

NCT05869669 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials