A Phase 2 interventional study of Neflamapimod and Placebo in Nonfluent Variant Primary Progressive Aphasia (nfvPPA), sponsored by EIP Pharma Inc. Active, not recruiting at 7 sites in 2 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by EIP Pharma Inc · Phase 2, Interventional, and Treatment
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.
Clinical diagnosis of nfvPPA by consensus criteria [Gorno-Tempini et al, 2011].
At least one of the following core features must be present:
At least 2 of 3 of the following other features must be present:
Exclusion Criteria:
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5.
The following additional exclusion criteria applies for participants undergoing (18F-Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography) 18F-FDG PET-CT (18F-FDG PET-CT scans are optional):
Drug: Neflamapimod
Drug: Placebo
Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α)
Placebo is a capsule that looks just like neflamapimod but without the active ingredients
Incidence of Adverse Events and Serious Adverse Events.
The number and proportion of participants experiencing adverse events (AEs) and serious adverse events (SAEs) during the study period, categorized by severity and relationship to the study intervention.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Digitized Speech Metrics
Participant will complete a series of tasks in which voice recordings will be captures. The voice recording will be analyzed for linguistic and acoustic metrics.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Letter Fluency Test (LFT)
The LFT is scored by counting the number of valid words a participant generates within a set time. Scores can range from 0 to 50. Higher scores indicate better verbal fluency and cognitive processing, while lower scores reflect difficulty in language, memory, and executive functioning.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Category Fluency Test (CFT)
The CFT is scored by counting the number of valid words a participant generates with in a specific category in a set time. Higher scores indicate better semantic memory and executive functioning, while lower scores reflect impairments in cognitive processing or language abilities.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Stroop Color and Word Test (SCWT)
The SCWT is scored based on the time taken to complete each of the four conditions and are scaled utilizing a norming method based upon participant age. Scaled scores range from 1 to 19. Faster times, and higher scaled scores, indicate stronger executive function.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Progressive Aphasia Severity Scale (PASS)
The PASS is a tool for rating the presence and severity of symptoms across speech, language and functional communication domains in participants with progressive aphasia. Individual domain scores range from 0 (normal) to 3 (severe impairment). Each individual domain is summed to provide a PASS Sum of Boxes Score. A higher PASS Sum of Boxes Score indicates greater severity of symptoms.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Northwestern Anagram Test (NAT)
The NAT examines non-verbal production of subject extracted wh-questions (SWh) and object extracted wh-questions (OWh). Scores for the NAT range from 0-10 (5 points each SWh- and OWh-Questions). A higher total score indicates better non-verbal sentence production, while a lower score reflects worse non-verbal sentence production.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Western Aphasia Battery-Revised (WAB-R)
The WAB-R is a test designed to assess a participant's language impairment. The WAB-R measures both linguistic and non-linguistic skills. The core measure of aphasia is the Aphasia Quotient (AQ) and is derived from the Spontaneous Speech, Auditory Verbal Comprehension, Repetition, Naming and Word Finding section scores. The AQ can range from 0 to 100 with higher scores indicating milder language impairment and the lower scores indicating greater language impairment.
Time frame: Baseline to Week 36
Change from Baseline to Week 36 in Clinical Dementia Rating Plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB)
The CDR® plus NACC FTLD is aimed at evaluating those suffering from or at risk for any of the forms of frontotemporal lobar degeneration. The CDR® plus NACC FTLD-SB is scored by summing ratings across 10 domains. Each domain is rated on a scale from 0 (no impairment) to 3 (serve impairment). The total score ranges from 0 to 30, where higher scores indicate greater cognitive and functional impairment.
Time frame: Baseline to Week 36
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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EIP Pharma Inc