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Could a pill help restore speech in progressive aphasia?

NCT ID NCT07033481

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

40 to 85 years

Sex

Anyone

Healthy volunteers

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

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

  • Clinical Ageing Research Unit, Campus for Ageing and Vitality, Biomedical Research Building

    Newcastle upon Tyne, NE4 5PL, United Kingdom

  • Columbia University

    New York, New York, 10032, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • The Ohio State University

    Columbus, Ohio, 43221, United States

  • Windsor Research Unit, Fulbourn Hospital

    Cambridge, CB21 5EF, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.