A Phase 2a Clinical Study of Neflamapimod in Patients with PPA
Research type
Research Study
Full title
A Phase 2a Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Primary Progressive Aphasia (PPA)
IRAS ID
1013112
Contact name
Mark De Rosch
Contact email
Sponsor organisation
CervoMed Inc.
Clinicaltrials.gov Identifier
Research summary
Approximately 12, and up to 20, male and female participants, aged 40 to 85 years, with a diagnosis of non-fluent variant Primary Progressive Aphasia (nfvPPA), will take part in this research study in the US and the UK. People with nfvPPA have increasing difficulty speaking. Their speech becomes slow and effortful and they may appear to be physically struggling to produce words; they make many grammatical errors and mistakes while speaking.
The study is divided into Screening and 2 Periods:
- Screening (35 days): patients will be assessed for eligibility in the study
- The first period is an open-label period where patients will receive neflamapimod for 24 weeks (6 months).
- The second period is a placebo-controlled, double-blind period (double-blind period). Double-blind means neither participants, participant’s caregiver, the study doctor, or study staff will know if participants are being given neflamapimod or placebo, but this can be determined if it is medically necessary. Placebo controlled means that some participants will receive placebo. Placebo is a product that has no active drug but looks exactly like neflamapimod. To try to make sure the groups are the same to start with, each participant is put into a group by chance (randomly). In the double-blind period, participants will have an equal chance of receiving neflamapimod or placebo. This means an equal number of study participants will get neflamapimod or placebo as the study drug, and whether you get neflamapimod or placebo is determined by chance.Participants will receive the study drug (neflamapimod or placebo) in the form of capsules, taken by mouth with food, two times a day. The overall study duration is up to 43 weeks (about 10 months).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0270
Date of REC Opinion
24 Dec 2025
REC opinion
Further Information Favourable Opinion