Actively Recruiting
Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia
Led by EIP Pharma Inc · Updated on 2026-04-22
20
Participants Needed
7
Research Sites
52 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
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.
CONDITIONS
Official 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 40-85 years at Screening.
- Participant or legally authorized representative willing and able to 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 sound errors (apraxia of speech).
- Presence of at least two of the following: impaired comprehension of complex sentences, spared single-word comprehension, 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 study assessments.
- Fluent in English as judged by Investigator.
- Reliable study partner able to attend all visits and understand English.
You will not qualify if you...
- Brain MRI not compatible with nfvPPA diagnosis.
- History or evidence of other CNS conditions causing aphasia or dementia, such as Alzheimer's disease, Dementia with Lewy Bodies, inflammatory/demyelinating conditions, Creutzfeldt Jakob disease, vascular dementia, post-stroke dementia.
- Prominent Parkinsonism, corticobasal syndrome, or progressive supranuclear palsy features exceeding language symptoms.
- Severe motor features impacting clinical or neuropsychological assessments.
- Positive plasma pTau217 or biomarkers indicating Alzheimer's disease pathology.
- Known progranulin (GRN) mutations.
- Major active psychiatric disorder or other medical condition compromising safety or study compliance.
- Metabolic or toxic encephalopathy or dementia due to other medical conditions.
- Neurosurgery to the brain within past five years.
- Active suicidality or history of suicide attempt within 2 years.
- Clinically relevant intellectual impairment interfering with study assessments.
- Diagnosis of alcohol or drug abuse within past 2 years.
- Poorly controlled significant medical illnesses (e.g., hypertension, recent myocardial infarction, heart failure, or other major diseases).
- Elevated liver enzymes or abnormal coagulation tests beyond specified limits.
- Known HIV, hepatitis B, or active hepatitis C infection.
- Participation in investigational drug or brain stimulation study less than 6 weeks prior.
- Male with female partner(s) of childbearing potential unwilling to use contraception.
- Female of childbearing potential with positive pregnancy test or unwilling to use contraception.
- Weight less than 50 kg at Screening.
- For participants undergoing optional PET-CT scans: blood glucose above 200 mg/dL or contraindications to PET scans.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here