Neflamapimod for Aphasia

Recruiting at 2 trial locations

Overseen By David Santos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: EIP Pharma Inc

Must not be taking: Anticoagulants

Disqualifiers: Alzheimer's, Dementia, Parkinsonism, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called neflamapimod for individuals with nonfluent variant primary progressive aphasia (nfvPPA), a condition affecting speech and language. The goal is to determine if neflamapimod is safe and effective in improving symptoms like effortful speech or difficulty with sentence structure. Participants will receive either the experimental drug or a placebo, a harmless pill without active medication. This trial may suit those diagnosed with nfvPPA who experience speech difficulties such as halting speech or trouble understanding complex sentences. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that neflamapimod is likely to be safe for humans?

Research shows that neflamapimod is generally safe for people. One study found serious side effects to be rare. The most common side effect was falls, affecting about 6 out of every 100 people taking the drug. Other side effects occurred even less frequently.

Neflamapimod has undergone previous testing in people, aiding researchers in understanding its safety. While side effects can occur, studies have ensured the treatment's safety. For those considering joining a trial, these findings suggest that neflamapimod is relatively safe based on past research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for aphasia?

Neflamapimod is unique because it targets a specific enzyme in the brain that plays a role in inflammation, potentially reducing brain inflammation associated with aphasia. Unlike most current treatments for aphasia, which primarily focus on speech therapy and rehabilitation techniques, Neflamapimod offers a pharmacological approach that directly interacts with brain chemistry. Researchers are excited about this treatment because it could provide a new way to improve language recovery by addressing the underlying biological processes, not just the symptoms.

What evidence suggests that neflamapimod might be an effective treatment for aphasia?

Research has shown that neflamapimod might help with certain brain conditions. In one study, patients with dementia who took neflamapimod showed significant improvement in their Clinical Dementia Rating compared to those who took a placebo. This suggests it might support brain function. Although it did not improve memory in patients with mild Alzheimer's, it affected other important brain markers. These results offer hope that neflamapimod, which participants in this trial may receive, could also help treat nonfluent variant primary progressive aphasia (nfvPPA), a condition affecting speech and language. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with nonfluent variant primary progressive aphasia (nfvPPA), a condition affecting speech and language. Participants should have a diagnosis of nfvPPA to be eligible. Specific inclusion and exclusion criteria details are not provided, but typically these would outline necessary health conditions and factors that could prevent someone from safely participating.

Inclusion Criteria

Participant or participant's legally authorized representative is willing and able to provide written informed consent

Fluent in English

Global CDR plus NACC FTLD score of 0.5 or 1 during Screening

Exclusion Criteria

Brain MRI incompatible with a diagnosis of nfvPPA

I have no brain conditions except for nfvPPA.

Suicidality within specified timeframes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neflamapimod or placebo and are monitored for safety, pharmacokinetics, and clinical effects

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neflamapimod

Trial Overview

The study tests neflamapimod against a placebo in people with nfvPPA. The aim is to assess the drug's safety, how it moves through the body (pharmacokinetics), and its potential effects on symptoms related to speech and language impairments caused by this type of aphasia.

How Is the Trial Designed?

Group I: Neflamapimod Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

EIP Pharma Inc

Lead Sponsor

Trials

7

Recruited

480+

Founded

Not available

Headquarters

Boston, USA

Known For

CNS Therapeutics

Top Products

Neflamapimod

CervoMed, Inc

Collaborator

Trials

2

Recruited

180+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07033481

NCT07033481 | Clinical Study of Neflamapimod in Patients ...

The goal of this exploratory study is to evaluate the effect of neflamapimod in participants with nonfluent variant primary progressive aphasia (nfvPPA).

2.

ir.cervomed.com

ir.cervomed.com/news-releases/news-release-details/cervomed-announces-new-data-phase-2b-trial-demonstrating

CervoMed Announces New Data from Phase 2b Trial ...

Significant improvement relative to placebo on primary outcome measure, change in Clinical Dementia Rating Sum of Boxes (CDR-SB), ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8157623/

A phase 2 double-blind placebo-controlled 24-week treatment ...

A 24-week treatment with 40 mg neflamapimod twice daily did not improve episodic memory in patients with mild AD. However, neflamapimod treatment lowered CSF ...

4.

tipranks.com

tipranks.com/news/company-announcements/cervomed-inc-s-promising-phase-2a-study-on-neflamapimod-for-aphasia

Cervomed Inc.'s Promising Phase 2a Study on ...

' The study aims to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in patients with nonfluent variant primary ...

5.

neurologylive.com

neurologylive.com/view/fda-feedback-provides-clarity-phase-3-trial-neflamapimod-dementia-lewy-bodies

FDA Feedback Provides Clarity for Phase 3 Trial of ...

Earlier this year, CervoMed announced positive results from RewinD-LB , demonstrating that treatment with neflamapimod significantly improved ...

6.

cervomed.com

cervomed.com/clinical-results/

Neflamapimod Clinical Results

Initial safety, biomarker and pharmacokinetic data from the trial is ... Scientific data for neflamapimod has been published in certain medical ...

7.

withpower.com

withpower.com/trial/phase-2-neurocognitive-disorders-7-2025-d3bdf

Neflamapimod for Aphasia

Prior Safety DataThis treatment has passed at least one previous human trial ... We aim to evaluate the safety, pharmacokinetics and clinical effects of ...