BMS-986368 for Alzheimer's Disease

Recruiting at 39 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

Trial Summary

What is the purpose of this trial?

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 Alzheimer's Disease.

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.

What data supports the effectiveness of the drug BMS-986368 for Alzheimer's Disease?

The research highlights that cholinesterase inhibitors, which are used for mild to moderate Alzheimer's, have shown moderate effects on cognition and daily activities. This suggests that drugs targeting similar pathways might also be effective. Additionally, using specific measures and patient groups in trials can improve the chances of detecting a drug's effectiveness. ^{1 2 3 4 5}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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 agitation is diagnosed as per the IPA standards.

NPI-NH agitation/aggression sub-score ≥ 4

My memory and thinking skills test score is below 21.

Exclusion Criteria

History of bipolar disorder, schizophrenia, or schizoaffective disorder

Other protocol-defined Inclusion/Exclusion criteria apply

Clinically significant delusions/hallucinations requiring hospitalization

Timeline

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

Treatment Details

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.

Participant Groups

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+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

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

Findings from Research

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]

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]

References

1. France 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? [2019]

2. Netherlands 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? [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Antidementia drugs--response or non-response?]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Ways toward an early diagnosis in Alzheimer's disease: the Alzheimer's Disease Neuroimaging Initiative (ADNI). [2022]

5. England pubmed.ncbi.nlm.nih.gov

A responder analysis of memantine treatment in patients with Alzheimer disease maintained on donepezil. [2018]