Active not recruitingPhase 2

Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia

A Phase 2a Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Primary Progressive Aphasia (PPA)

Lead sponsor

EIP Pharma Inc

Asset

Neflamapimod

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Frontotemporal dementia

Key I/E criteria

•CDR global 0.5•Study partner/caregiver required

Primary endpoint

•Adverse Events and Serious Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCRVO24-NFD-701

NCT IDNCT07033481

Timeline

Milestones

Study first posted2025-06-24actual

Study start2025-10-02actual

Last update posted2026-07-06actual

Primary completion2026-09estimated (month precision)

Study completion2026-10estimated (month precision)

Assets

Drug assets

Neflamapimod

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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 comprehension of syntactically complex sentences

2. Spared single-word comprehension

3. 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

Exclusion criteria

•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).

•Known progranulin (GRN) mutations.

•Ongoing major and active psychiatric disorder and/or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.

•Metabolic or toxic encephalopathy or dementia due to a general medical condition.

•History of previous neurosurgery to the brain within the past five years.

•Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide.

•Clinically relevant intellectual impairment that may interfere with the ability to complete the study scales and assessments, at the discretion of the Investigator.

•Diagnosis of alcohol or drug abuse within the previous 2 years.

•Poorly controlled clinically significant medical illness, such as hypertension; myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety.

•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.

-If participant has a documented history of Gilbert's syndrome, criterion of total bilirubin >1.5 x ULN is not applicable.

-If participant is taking anticoagulants (e.g., warfarin), and has no known liver issues, INR >3.

•Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection.

•Participated in a study of an investigational drug or transcranial direct current stimulation less than 6 weeks or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.

•Male with female partner(s) of childbearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol.

•Female of childbearing potential (see Section 5.10), with a positive pregnancy test result during Screening and are unwilling or unable to adhere to contraception requirements specified in the protocol.

•Weight less than 50 kg at Screening.

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):

•Blood glucose levels >200 mg/dL.

•Contraindications to having a PET scan.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Executive function / language

Memory

Global cognition

Safety / tolerability / PK

Other (unclassified)

Global cognition

1 endpoint

Other/protocol endpoint

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)

Time frame:Baseline to Week 36

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Memory

2 endpoints

Other/protocol endpoint

Change from Baseline to Week 36 in Letter Fluency Test (LFT)

Time frame:Baseline to Week 36

change from baseline, improvement

Other/protocol endpoint

Change from Baseline to Week 36 in Category Fluency Test (CFT)

Time frame:Baseline to Week 36

change from baseline, improvement

Executive function / language

4 endpoints

Other/protocol endpoint

Change from Baseline to Week 36 in Digitized Speech Metrics

Time frame:Baseline to Week 36

change from baseline, improvement

Other/protocol endpoint

Change from Baseline to Week 36 in Stroop Color and Word Test (SCWT)

Time frame:Baseline to Week 36

change from baseline, improvement

Other/protocol endpoint

Change from Baseline to Week 36 in Progressive Aphasia Severity Scale (PASS)

Time frame:Baseline to Week 36

change from baseline, improvement

Other/protocol endpoint

Change from Baseline to Week 36 in Western Aphasia Battery-Revised (WAB-R)

Time frame:Baseline to Week 36

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence of Adverse Events and Serious Adverse Events.

Time frame:Baseline to Week 36

threshold achievement, event

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Change from Baseline to Week 36 in Northwestern Anagram Test (NAT)

Time frame:Baseline to Week 36

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.