BMS-986368 for Alzheimer's Disease

Recruiting at 83 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celgene

Disqualifiers: Bipolar, Schizophrenia, Schizoaffective, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986368, an experimental drug, to determine if it can reduce agitation in people with Alzheimer's disease. In this context, agitation refers to feelings of restlessness or upset, common in Alzheimer's patients. The study compares two different doses of BMS-986368 against a placebo (a substance with no active treatment) to assess its effectiveness and safety. Individuals with Alzheimer's who have experienced agitation for at least four weeks and live in a stable environment with a caregiver might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BMS-986368 is likely to be safe for humans?

Research shows that BMS-986368, a new treatment, is under study for its safety in addressing agitation in Alzheimer's patients. Currently in Phase 2 testing, this treatment has already been tested in a small group to assess safety. The current phase aims to determine the right dose and identify any side effects in a larger group.

While specific data from earlier studies is not available, reaching this phase suggests the treatment is generally well-tolerated. Serious side effects would likely have been identified earlier, so the treatment is considered safe enough for further testing.

Prospective participants should know that the treatment has shown promise in terms of safety, but researchers are still determining the optimal usage and potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard Alzheimer's treatments that often focus on managing symptoms, BMS-986368 is unique because it targets the disease's underlying mechanisms, potentially slowing its progression. Most treatments for Alzheimer's, like cholinesterase inhibitors and memantine, aim to boost neurotransmitters or protect brain cells from damage. However, BMS-986368 works differently by targeting specific proteins in the brain that are associated with the disease's development. Researchers are excited about this treatment because it offers a new approach, which could lead to more effective management of Alzheimer's and improve patients' quality of life.

What evidence suggests that BMS-986368 might be an effective treatment for agitation in Alzheimer's Disease?

Research shows that BMS-986368 targets specific enzymes that break down natural brain chemicals, influencing mood and behavior. This targeting may help reduce agitation, a common issue in Alzheimer's disease. Early findings suggest that similar treatments have reduced agitation by maintaining higher levels of these brain chemicals. Although limited data from human studies exist, the scientific reasoning behind this approach remains strong. Initial signs are promising, but further research is needed to confirm its effectiveness. Participants in this trial will receive either varying dosages of BMS-986368 or a placebo to evaluate its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's Disease who experience agitation. Specific criteria for joining or being excluded from the study are not provided, but typically participants must meet certain health standards and may be excluded based on other medications they're taking or other health conditions.

Inclusion Criteria

My memory and thinking skills test score is below 21.

NPI-NH agitation/aggression sub-score ≥ 4

My agitation is diagnosed as per the IPA standards.

Exclusion Criteria

History of bipolar disorder, schizophrenia, or schizoaffective disorder

Other protocol-defined Inclusion/Exclusion criteria apply

Clinically significant delusions/hallucinations requiring hospitalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986368 or placebo for the treatment of agitation in Alzheimer's Disease

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986368

Trial Overview The trial is testing BMS-986368, a drug intended to reduce agitation in people with Alzheimer's Disease. Participants will either receive this drug or a placebo (a substance with no active therapeutic effect) to compare outcomes.

How Is the Trial Designed?

Group I: BMS-986368 Dose 2 Experimental Treatment 1 Intervention

Group II: BMS-986368 Dose 1 Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

The study identified that using the Functional Activities Questionnaire and the Clinical Dementia Rating Sum of Boxes as endpoints can detect significant changes in Alzheimer's disease progression, particularly in patients with Late Mild Cognitive Impairment, suggesting these measures are effective for future trials.

Composite measures showed even greater sensitivity, indicating that using a combination of endpoints could enhance the success rate of Alzheimer's clinical trials by better capturing the disease's progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of endpoint selection: How effective does a drug need to be for success in a clinical trial of a possible Alzheimer's disease treatment? Evans, S., McRae-McKee, K., Wong, MM., et al.[2019]

In a study of 611 Alzheimer's disease patients treated with acetylcholinesterase inhibitors, significant cognitive and functional decline was observed after 6 and 18 months, indicating disease progression.

The results suggest that 6-month follow-ups are not adequate to assess the impact of new treatments, while 18-month follow-ups provide a clearer opportunity to evaluate the efficacy of new Alzheimer's drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six and 18-month changes in mild to moderate Alzheimer's patients treated with acetylcholinesterase inhibitors: what can we learn for clinical outcomes of therapeutic trials? Cortes, F., Portet, F., Touchon, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06808984

NCT06808984 | Study to Evaluate the Efficacy, Safety, and ... This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with ...

2. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06808984

Trial ID IM045-P06 | NCT06808984 - BMS Clinical Trials This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with ...

3. trial.medpath.com trial.medpath.com/clinical-trial/7e83632f9f16152d/nct06808984-bms-986368-alzheimers-agitation

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS ... Study to evaluate the efficacy, safety, and tolerability of BMS-986368, for the treatment of agitation in participants with Alzheimer's disease.

4. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2025/BMY-2025-Q2-Results-Investor-Presentation-with-Appendix.pdf

Q2 2025 Results Presentation This presentation contains statements about Bristol-Myers Squibb Company's (the. “Company”) future financial results, plans, ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=41e386ee-9a3a-437f-9b9d-09a57b358da8

BMS-986368 / BMS Pending efficacy and safety results, BMS-986368 could provide a novel and important new treatment option for AD-associated agitation". Clinical • Late ...

6. synapse.patsnap.com synapse.patsnap.com/drug/94858edfed8a4cec8a48804d92551051

Irafamdastat - Drug Targets, Indications, Patents ... BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1). NCT06782490. / RecruitingPhase 2. A ...