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Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia

ConditionNonfluent Variant Primary Progressive Aphasia (nfvPPA)
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Neflamapimod

    Drug

    Neflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40 mg capsules

  • Placebo

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: NeflamapimodExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EIP Pharma Inc

Lead sponsor

CervoMed, Inc.

Collaborator

Source ClinicalTrials.gov
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