Could a pill help restore speech in progressive aphasia?
NCT ID NCT07033481
First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests a drug called neflamapimod in 20 people with a language disorder called nonfluent variant primary progressive aphasia (nfvPPA). The goal is to see if the drug is safe and if it can improve language symptoms. Participants will receive either the drug or a placebo for a set period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neflamapimod
- What this could lead to
- If it works, this could point toward a treatment that eases language symptoms in people with primary progressive aphasia.
- What could go wrong
- This is a very small, early-phase study with only 20 participants. It is primarily testing safety, so it may not show clear benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 \[Gorno-Tempini et al, 2011\]. * At least one of the following core features must be present: 1. Agrammatism in language production 2. Effortful, halting speech with inconsistent speech sound errors and distortions (apraxia of speech) * At least 2 of 3 of the following other features must be present: 1. Impaired comprehension of syntactically complex sentences 2. Spared single-word comprehension 3. Spared object knowledge * Global CDR® plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration (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 auditory abilities, sufficient to perform all aspects of the study scales and assessments. * Fluent in English, per Investigator judgement. * Must have reliable study partner that is able to attend all study visits with participant. Study partner must be able to read, write, and understand the English language. 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 Aβ42/40 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. * Poorly controlled clinically significant medical illness, such as hypertension; myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would interfere with assessment of drug safety. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 × the upper limit of normal (ULN), total bilirubin \>1.5 × ULN, and/or International Normalized Ratio (INR) \>1.5. * If participant has a documented history of Gilbert's syndrome, criterion of total bilirubin \>1.5 x ULN is not applicable. * If participant is taking anticoagulants (e.g., warfarin), and has no known liver issues, INR \>3. * Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus infection. * Participated in a study of an investigational drug or transcranial direct current stimulation less than 6 weeks or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study. * Male with female partner(s) of childbearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol. * Female of childbearing potential (see Section 5.10), with a positive pregnancy test result during Screening and are unwilling or unable to adhere to contraception requirements specified in the protocol. * Weight less than 50 kg at Screening. The following additional exclusion criteria applies for participants undergoing (18F-Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography) 18F-FDG PET-CT (18F-FDG PET-CT scans are optional): * Blood glucose levels \>200 mg/dL. * Contraindications to having a PET scan.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Ageing Research Unit, Campus for Ageing and Vitality, Biomedical Research Building
Newcastle upon Tyne, NE4 5PL, United Kingdom
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Columbia University
New York, New York, 10032, United States
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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The Ohio State University
Columbus, Ohio, 43221, United States
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Windsor Research Unit, Fulbourn Hospital
Cambridge, CB21 5EF, United Kingdom
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