ClinicalTrials.gg
Active, not recruitingNCT07033481Updated Jul 6, 2026

Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia

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.

Primary conditionAphasia, Primary ProgressiveRegistry: Brain DiseasesReclassifiedWhy we changed it
Registry
Brain Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aphasia, Primary Progressive
Why
  1. The study's listed conditions name Aphasia, Primary Progressive, a narrower term within Brain Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by EIP Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nonfluent Variant Primary Progressive Aphasia (nfvPPA)

Keywords

  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Neurocognitive Disorders
  • Mental Disorders
  • Neurodegenerative Diseases
  • Aphasia
  • Language Disorder
  • Frontotemporal Dementia
  • Speech and Language Disorder
  • Primary Progressive Aphasia
03

In context

Aphasia, Primary Progressive Reclassified

77 studies on the registry are indexed under Aphasia, Primary Progressive; 29 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 60 interventional studies indexed under Aphasia, Primary Progressive.

Browse Aphasia, Primary Progressive studies →

Lead sponsor

EIP Pharma Inc is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Compared within Aphasia, Primary Progressive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

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.
  • 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.
  • (AST) or alanine aminotransferase (ALT) >2 × the (ULN), total >1.5 × ULN, and/or (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 , , or active virus infection.
  • Participated in a study of an 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 , unwilling or unable to adhere to 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.
  • to having a PET scan.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Neflamapimod

    Drug: Neflamapimod

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α)

  • DrugPlacebo

    Placebo is a capsule that looks just like neflamapimod but without the active ingredients

06

What researchers measure

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

7 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Sep 2026, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 13, 2025
First posted
Jun 24, 2025
StartActual
Oct 2, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Oct 2026
Last update
Jul 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07033481
Lead sponsor
EIP Pharma Inc
Collaborators
CervoMed, Inc.
Responsible party
Sponsor
First posted
Jun 24, 2025
Start date
Oct 2, 2025
Primary completion
Sep 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jul 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: VX-745

Start the discussion