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Hope for Alzheimer's agitation: new drug enters final testing

NCT ID NCT05397639

Symptom relief Sponsor: Suven Life Sciences Limited Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 3 times

Summary

This study tests whether masupirdine, a daily tablet, can safely reduce agitation in people with Alzheimer's dementia. About 375 participants will receive either masupirdine or a placebo. The main goal is to see if the drug improves agitation symptoms, which can include aggression and restlessness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
masupirdine (SUVN-502)
What this could lead to
If it works, this could provide a new treatment option to reduce agitation in people with Alzheimer's dementia, improving quality of life.
What could go wrong
This is a phase 3 trial, but previous studies may have failed or shown modest effects. Agitation is hard to measure, and the drug may not outperform placebo or could have side effects.
Why investors are watching

Suven Life Sciences, a small public company, is running a phase 3 trial of masupirdine in 375 people with Alzheimer's-related agitation. Agitation is a hard-to-treat symptom, and this is the company's late-stage test of whether the drug eases it. For a company this size, one phase 3 readout can shape its whole story.

If it works: If masupirdine eases agitation better than placebo, Suven could point to a positive late-stage result in a symptom with few good options, which may support regulatory talks and partnering interest.

If it fails: If the drug fails to beat placebo or the trial is delayed, Suven would have spent a large late-stage effort without a win. Phase 3 trials often fail, and a small company has limited room to absorb that.

AI-written from the trial record. Speculative, and not investment advice.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 375 people

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

Started

Nov 2022

Expected to finish

Dec 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

50 to 90 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: * Has a diagnosis of dementia of the Alzheimer's type according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. * Has confirmed agitation using the IPA Consensus Provisional Definition of Agitation in Cognitive Disorders. * Has a score between 8 and 24 (both inclusive) on Mini-Mental State Examination (MMSE). Exclusion Criteria: * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia) * Has symptoms of agitation that are not secondary to Alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced). * Participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation Alzheimer's type dementia

Contacts and locations

Locations

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626-4607, United States

  • Advanced Research Center, Inc.

    Anaheim, California, 92805-5854, United States

  • Allied Biomedical Research Institute

    Miami, Florida, 33125-2607, United States

  • Baylor College of Medicine

    Houston, Texas, 77030-4202, United States

  • Brainstorm Research

    Miami, Florida, 33176, United States

  • CCM Clinical Research Group

    Miami, Florida, 33133, United States

  • Central Miami Medical Institute

    Miami, Florida, 33125, United States

  • Centrum Leczenia Zaburzen Pamieci Affidea

    Warsaw, Masovian Voivodeship, 04-148, Poland

  • Centrum Medyczne Silmedic Sp z o o

    Katowice, Silesian Voivodeship, 40-282, Poland

  • ClinHouse Centrum Medyczne

    Zabrze, 41-807, Poland

  • Clinical Centre of Vojvodina, Clinic of Neurology

    Novi Sad, 21000, Serbia

  • Clinical Hospital Center Dragisa Misovic Dedinje

    Belgrade, 11000, Serbia

  • Clinical Hospital Center Rijeka

    Rijeka, 51000, Croatia

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • EMC Silesia Sp. z o.o.

    Katowice, Silesian Voivodeship, 40-353, Poland

  • FutureMeds Warszawa Centrum

    Warsaw, Masovian Voivodeship, 00-215, Poland

  • Gadolin Research

    Beaumont, Texas, 77702, United States

  • Insight Hospital and Medical Center Chicago

    Chicago, Illinois, 60616, United States

  • Ki Health Partners, LLC

    Stamford, Connecticut, 06905, United States

  • Klinika za psihijatriju Vrapce

    Zagreb, 10090, Croatia

  • Leading Edge Research LA, LLC

    Encino, California, 91316, United States

  • MTZ Clinical Research powered by Pratia

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Mary S Easton Center for Alzheimer's Research and Care UCLA

    Los Angeles, California, 90095, United States

  • Medycyna Milorzab sp. z o.o.

    Lodz, Lódzkie, 90-227, Poland

  • Miami Jewish Health

    Miami, Florida, 33137, United States

  • Midlands Neurology and Pain Associates

    Columbia, South Carolina, 29205, United States

  • Neuro Pain Medical Center

    Fresno, California, 93710-5473, United States

  • Neuro-Medic Janusz Zbrojkiewicz

    Katowice, Silesian Voivodeship, 40-686, Poland

  • Neurology Center of North Orange County

    Fullerton, California, 92835-1040, United States

  • Novel Clinical Research Center, LLC.

    Miami, Florida, 33143, United States

  • Ocean Medical Research

    Toms River, New Jersey, 08755, United States

  • Polyclinic Neuron

    Zagreb, 10000, Croatia

  • Quantum Laboratories Inc

    Pompano Beach, Florida, 33064, United States

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401-1113, United States

  • Re:Cognition Health

    Chicago, Illinois, 60611, United States

  • Re:Cognition Health

    Fort Worth, Texas, 76104, United States

  • Special Hospital for Psychiatric Diseases

    Kovin, 26220, Serbia

  • University Clinical Center Kragujevac, Clinic for Psychiatry

    Kragujevac, 34000, Serbia

  • University Clinical Center Nis, Clinic for neurology

    Niš, 18000, Serbia

  • University Hospital Center Zagreb

    Zagreb, 10000, Croatia

  • Velocity Clinical Research, Cleveland

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057, United States

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