A Phase 2a Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Primary Progressive Aphasia (PPA)
EIP Pharma Inc
Summary
The goal of this exploratory study is to evaluate the effect of neflamapimod in participants with nonfluent variant primary progressive aphasia (nfvPPA). We aim to evaluate the safety, pharmacokinetics and clinical effects of neflamapimod of participants with nfvPPA.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Men and women aged 40-85 years at Screening. * Participant or participant's legally authorized representative (where applicable) is willing and able to provide written informed consent. * Clinical diagnosis of nfvPPA by consensus criteria \[Gorno-Tempini et al, 2011\]. * At least one of the following core features must be present: 1. Agrammatism in language production 2. Effortful, halting speech with inconsistent speech sound errors and distortions (apraxia of speech) * At least 2 of 3 of the following other features must be present: 1. Impaired compr…
Interventions
- DrugNeflamapimod
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40 mg capsules
- DrugPlacebo
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Locations (7)
- Northwestern Memorial HospitalChicago, Illinois
- Mayo ClinicRochester, Minnesota
- Columbia UniversityNew York, New York
- The Ohio State UniversityColumbus, Ohio
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
- Windsor Research Unit, Fulbourn HospitalCambridge