Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorEIP Pharma Inc
About this trial
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 criteria
Qualifiers
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].
Agrammatism in language production
Disqualifiers
Brain Magnetic Resonance Image (MRI) incompatible with a diagnosis of nfvPPA.
History or evidence of a central nervous system (CNS) condition other than nfvPPA which may cause symptoms of aphasia or dementia, including but not limited to Alzheimer's disease (AD), Dementia with Lewy Bodies (DLB), inflammatory/demyelinating CNS conditions, Creutzfeldt Jakob disease, vascular dementia, post-stroke dementia, etc.
Features or Parkinsonism, corticobasal syndrome or progressive supranuclear palsy that are as or more prominent than the language features of nfvPPA, and/or motor features which are sufficiently severe that they could significantly impact performance on any of the clinical or neuropsychological measures.
Plasma pTau217 result with a high likelihood of the presence of amyloid pathology at Screening or documented evidence of positive biomarkers associated with Alzheimer's disease pathology (e.g., abnormal plasma Aβ42/40 ratio, abnormal CSF phospo-tau/amyloid ratio, or presence of amyloid tracer update on brain amyloid positron emission tomography [PET] imaging).
Trial design
Treatments tested in this trial
- Neflamapimod
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
EIP Pharma Inc
Lead sponsor
CervoMed, Inc.
Collaborator
Source ClinicalTrials.gov