A Phase 2a Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Primary Progressive Aphasia (PPA)
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.
• 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:
• Agrammatism in language production
∙ 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:
• Impaired comprehension of syntactically complex sentences
∙ Spared single-word comprehension
∙ Spared object knowledge
• Global CDR® plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration (NACC FTLD) score of 0.5 or 1 during Screening.
• CDR® plus NACC FTLD language domain score of 0.5, 1 or 2 during Screening.
• Normal or corrected eyesight and auditory abilities, sufficient to perform all aspects of the study scales and assessments.
• Fluent in English, per Investigator judgement.
• Must have reliable study partner that is able to attend all study visits with participant. Study partner must be able to read, write, and understand the English language.