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New pill could calm agitation in Alzheimer's patients

NCT ID NCT06808984

Symptom relief Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study tests an experimental oral medication (BMS-986368) to reduce agitation in people with Alzheimer's disease. About 120 participants will receive either a low dose, high dose, or placebo. The main goal is to see if the drug safely decreases agitated behaviors, such as pacing or yelling, over several weeks.

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 120 people

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

Started

Jun 2025

Expected to finish

Jan 2028

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

55 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 * Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation. * History of agitation with onset at least four weeks prior to Screening. * MMSE-1 score ≤24. * NPI-NH agitation/aggression sub-score ≥ 4. * Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver). * Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable. Exclusion Criteria * Clinically significant delusions/hallucinations requiring hospitalization. * History of bipolar disorder, schizophrenia, or schizoaffective disorder. * History of major depressive episode with psychotic features during the 12 months prior to Screening. * History of delirium within 30 days of Screening. * Other protocol-defined Inclusion/Exclusion criteria apply.

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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 disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    65 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ANESC Research

    RECRUITING

    El Paso, Texas, 79912, United States

  • Arrow Clinical Trials

    RECRUITING

    Daytona Beach, Florida, 32117, United States

  • Be Well Clinical Studies

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Be Well Clinical Studies - Omaha

    RECRUITING

    Omaha, Nebraska, 68144, United States

  • Boeson Research

    RECRUITING

    Missoula, Montana, 59804, United States

  • Boeson Research - Provo

    RECRUITING

    Provo, Utah, 84604, United States

  • CenExel iResearch, LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Charter Research - Lady Lake

    RECRUITING

    The Villages, Florida, 32162, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • ClinCloud

    RECRUITING

    Maitland, Florida, 32751, United States

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20057, United States

  • Horizon Clinical Research Center - Houston

    RECRUITING

    Cypress, Texas, 77065, United States

  • Inland Psychiatric Medical Group.

    RECRUITING

    Chino, California, 91710, United States

  • K2 Medical Research

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Kaizen Brain Center

    RECRUITING

    La Jolla, California, 92037, United States

  • Local Institution - 0001

    NOT_YET_RECRUITING

    Tampa, Florida, 33607, United States

  • Local Institution - 0004

    COMPLETED

    Honolulu, Hawaii, 96817, United States

  • Local Institution - 0007

    NOT_YET_RECRUITING

    Maitland, Florida, 32751, United States

  • Local Institution - 0010

    COMPLETED

    Miami, Florida, 33166, United States

  • Local Institution - 0011

    NOT_YET_RECRUITING

    Marrero, Louisiana, 70072, United States

  • Local Institution - 0017

    NOT_YET_RECRUITING

    Anaheim, California, 92805, United States

  • Local Institution - 0020

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Local Institution - 0022

    WITHDRAWN

    Miami, Florida, 33125, United States

  • Local Institution - 0024

    COMPLETED

    Flower Mound, Texas, 75028, United States

  • Local Institution - 0026

    COMPLETED

    Atlanta, Georgia, 30318, United States

  • Local Institution - 0028

    COMPLETED

    West Hills, California, 91307, United States

  • Local Institution - 0031

    NOT_YET_RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • Local Institution - 0040

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Local Institution - 0041

    COMPLETED

    Las Vegas, Nevada, 89121, United States

  • Local Institution - 0043

    COMPLETED

    Sherman Oaks, California, 91403, United States

  • Local Institution - 0046

    NOT_YET_RECRUITING

    Homewood, Alabama, 35209, United States

  • Local Institution - 0048

    COMPLETED

    Phoenix, Arizona, 85028, United States

  • Local Institution - 0051

    NOT_YET_RECRUITING

    South Dartmouth, Massachusetts, 02747, United States

  • Local Institution - 0053

    WITHDRAWN

    Washington D.C., District of Columbia, 20060, United States

  • Local Institution - 0059

    NOT_YET_RECRUITING

    Livingston, New Jersey, 07039, United States

  • Local Institution - 0064

    COMPLETED

    Staten Island, New York, 10309, United States

  • Local Institution - 0068

    NOT_YET_RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1060AAE, Argentina

  • Local Institution - 0069

    NOT_YET_RECRUITING

    Buenos Aires, C1405BOA, Argentina

  • Local Institution - 0071

    NOT_YET_RECRUITING

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Local Institution - 0072

    NOT_YET_RECRUITING

    Mendoza, 5500, Argentina

  • Local Institution - 0073

    NOT_YET_RECRUITING

    Santiago del Estero, 4200, Argentina

  • Local Institution - 0074

    NOT_YET_RECRUITING

    Córdoba, Córdoba Province, X5147, Argentina

  • Local Institution - 0075

    NOT_YET_RECRUITING

    Córdoba, 5004, Argentina

  • Local Institution - 0076

    NOT_YET_RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Local Institution - 0077

    NOT_YET_RECRUITING

    Darlinghurst, 2010, Australia

  • Local Institution - 0078

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0079

    NOT_YET_RECRUITING

    Wangaratta, Victoria, 3677, Australia

  • Local Institution - 0080

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

  • Local Institution - 0081

    NOT_YET_RECRUITING

    Toms River, New Jersey, 08755, United States

  • Local Institution - 0082

    NOT_YET_RECRUITING

    Shanghai Shi, Shanghai Municipality, 200030, China

  • Local Institution - 0083

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310014, China

  • Local Institution - 0084

    NOT_YET_RECRUITING

    Hefei, Anhui, 230022, China

  • Local Institution - 0085

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Local Institution - 0086

    WITHDRAWN

    Elgin, Illinois, 60123, United States

  • Local Institution - 0087

    NOT_YET_RECRUITING

    Columbus, Ohio, 43221, United States

  • Local Institution - 0088

    NOT_YET_RECRUITING

    Sterling Heights, Michigan, 48312, United States

  • Local Institution - 0089

    NOT_YET_RECRUITING

    Ardmore, Oklahoma, 73401, United States

  • Local Institution - 0090

    NOT_YET_RECRUITING

    Daw Park, South Australia, 5041, Australia

  • Local Institution - 0091

    NOT_YET_RECRUITING

    Richardson, Texas, 75082, United States

  • Local Institution - 0092

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Local Institution - 0093

    NOT_YET_RECRUITING

    Wuhan, HUB, 430060, China

  • Mid Hudson Medical Research

    RECRUITING

    New Windsor, New York, 12553, United States

  • Neurology Clinic, P.C.

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • New Hope Clinical Research

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • Next Level Clinical Trials

    RECRUITING

    West Covina, California, 91790, United States

  • Pinnacle Clinical Research

    RECRUITING

    Austin, Texas, 78626, United States

  • Research Central LLC (DBA Ichor Research)

    RECRUITING

    Syracuse, New York, 13210, United States

  • Shreenath Clinical Service - Lakewood

    RECRUITING

    Lakewood, California, 90805, United States

  • Stryde Research - Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Feinstein Institute for Medical Research

    RECRUITING

    Manhasset, New York, 11030, United States

  • Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UNC Health REX Hospital

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • University at Buffalo - UBMD Neurology

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Alabama - Huntsville Regional Medical Campus

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • University of California San Diego - La Jolla

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Vanderbilt University Medical Center- Village

    RECRUITING

    Nashville, Tennessee, 37212, United States

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