๐๏ธ Verified NIH Record โข Updated 2026-07-01
Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia (NCT07033481)
๐ต Active, Not Recruiting Phase2 ๐ Investigational Drug / Biologic Sponsor: EIP Pharma Inc
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (22 items).
Location: Northwestern Memorial Hospital โ Chicago, Illinois
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 Aฮฒ42/40 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.
- Clinically relevant 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (7 Sites)
- Northwestern Memorial Hospital โ Chicago, Illinois
- Mayo Clinic โ Rochester, Minnesota
- Columbia University โ New York, New York
- The Ohio State University โ Columbus, Ohio
- Hospital of the University of Pennsylvania โ Philadelphia, Pennsylvania
- Windsor Research Unit, Fulbourn Hospital โ Cambridge,
- Clinical Ageing Research Unit, Campus for Ageing and Vitality, Biomedical Research Building โ Newcastle upon Tyne,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.