Actively Recruiting
A Phase 2a Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients With Primary Progressive Aphasia (PPA)
Led by EIP Pharma Inc · Updated on 2026-04-22
20
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
Sponsors
E
EIP Pharma Inc
Lead Sponsor
C
CervoMed, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of neflamapimod in people with nonfluent variant primary progressive aphasia (nfvPPA), a condition that affects speech and language. This phase 2a study aims to assess the safety, how the drug moves through the body, and its clinical effects in participants with this specific type of aphasia. The study is sponsored by EIP Pharma Inc and involves a controlled comparison to better understand neflamapimod's impact. Participants will receive either neflamapimod, a drug that specifically inhibits the p38 alpha kinase enzyme, or a placebo that looks identical but contains no active ingredients. The drug is provided in 40 mg capsules. The study is randomized and quadruple-blinded, meaning neither participants nor researchers know who receives the drug or placebo. The treatment period lasts 36 weeks, during which the incidence of adverse events will be closely monitored. Throughout the study, participants will attend regular visits for assessments including safety checks and clinical evaluations related to their aphasia. Study partners who can reliably attend visits and assist participants are required. Researchers will measure adverse events to evaluate participant safety. The total involvement includes the treatment and monitoring period up to 36 weeks, with detailed evaluations to understand the drug's effects and safety profile.
CONDITIONS
Brief Title
Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 40 to 85 years at screening
- Participant or legally authorized representative can provide written informed consent
- Clinical diagnosis of nonfluent variant primary progressive aphasia (nfvPPA) by consensus criteria
- Presence of at least one core feature: agrammatism in language production or effortful, halting speech with inconsistent speech errors (apraxia of speech)
- Presence of at least two of the following: impaired comprehension of complex sentences, spared single-word comprehension, or spared object knowledge
- Global CDR plus 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 hearing sufficient for assessments
- Fluent in English as judged by investigator
- Must have a reliable study partner able to attend all visits and understand English
You will not qualify if you...
- Brain MRI results inconsistent with nfvPPA diagnosis
- History or evidence of other central nervous system conditions causing aphasia or dementia (e.g., Alzheimer's disease, dementia with Lewy bodies, vascular dementia, post-stroke dementia)
- Parkinsonism, corticobasal syndrome, or progressive supranuclear palsy symptoms more prominent than language features or severe motor symptoms impacting assessments
- Positive biomarkers indicating Alzheimer's disease pathology
- Known progranulin (GRN) gene mutations
- Major active psychiatric disorders or other medical conditions compromising safety or compliance
- Metabolic or toxic encephalopathy or dementia from general medical conditions
- Neurosurgery to the brain within past five years
- Suicidal thoughts or attempts within specified recent periods
- Significant intellectual impairment interfering with assessments
- Diagnosis of alcohol or drug abuse within past two years
- Poorly controlled major medical illnesses affecting safety assessment
- Elevated liver enzymes or coagulation issues beyond set limits
- Known HIV, hepatitis B, or active hepatitis C infection
- Recent participation in other investigational drug or brain stimulation studies
- Contraception non-compliance in males with partners of childbearing potential or females of childbearing potential with positive pregnancy test
- Weight less than 50 kg
- For optional PET-CT scans: blood glucose over 200 mg/dL or contraindications to PET scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks
Participants receive neflamapimod or placebo capsules as part of the study treatment.
Regular visits during the treatment period
Trial Site Locations
Total: 7 locations
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Active, Not Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
3
Columbia University
New York, New York, United States, 10032
Active, Not Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43221
Active, Not Recruiting
5
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
6
Windsor Research Unit, Fulbourn Hospital
Cambridge, United Kingdom, CB21 5EF
Actively Recruiting
7
Clinical Ageing Research Unit, Campus for Ageing and Vitality, Biomedical Research Building
Newcastle upon Tyne, United Kingdom, NE4 5PL
Actively Recruiting
Research Team
A
Amanda Gardner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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