What is the mechanism of action of this treatment?

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors, NMDA receptor antagonists, and monoclonal antibodies targeting amyloid-beta. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) increase acetylcholine levels to improve cognitive function. NMDA receptor antagonists (e.g., memantine) regulate glutamate activity to prevent neuronal damage. Monoclonal antibodies (e.g., aducanumab) target and reduce amyloid-beta plaques. These treatments are vital as they aim to slow disease progression and alleviate symptoms, thereby enhancing the quality of life for AD patients.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine. Cholinesterase inhibitors often cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, along with muscle cramps, fatigue, and insomnia. Memantine can lead to dizziness, headache, confusion, and constipation. These side effects can vary in severity, sometimes requiring medication adjustments or switches.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which work by increasing cholinergic transmission to provide symptomatic relief. Memantine, another approved drug, acts as an NMDA receptor antagonist to help with moderate to severe Alzheimer's symptoms. More recently, aducanumab, a monoclonal antibody targeting amyloid-beta plaques, received approval despite mixed trial results and concerns about adverse effects like amyloid-related imaging abnormalities (ARIA). These treatments aim to manage symptoms and slow disease progression, although their efficacy varies.

What other types of research exist?

Promising novel alternatives for Alzheimer's Disease treatment in 2024 include: 1) Lecanemab, a monoclonal antibody targeting amyloid-beta, which has shown efficacy in slowing cognitive decline. 2) Donanemab, another amyloid-beta targeting antibody, which has demonstrated positive results in clinical trials. 3) Tau protein inhibitors, such as semorinemab, which target tau tangles, a hallmark of AD pathology. These treatments represent significant advancements in disease-modifying therapies for Alzheimer's Disease.

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BMS-984923 for Alzheimer's Disease

Verified Trial

Phase 1

Recruiting

Led By Stephanie Post, MD

Research Sponsored by Allyx Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours after last dose

Summary

This trial tests a new drug, BMS-984923, in healthy older adults and early Alzheimer's patients. It aims to see if the drug is safe and can help restore brain cell connections, measured by PET scans.

Who is the study for?

This trial is for men and women aged 50-80 without cognitive impairment, able to consent and follow study rules. Women must be postmenopausal or unable to have children; men must use condoms if with a woman who can bear children. Participants should score over 25 on the MOCA test.

What is being tested?

The study tests BMS-984923's safety and tolerability in older adults and Alzheimer's patients by comparing it with a placebo. It involves gradually increasing doses to see how participants respond.

What are the potential side effects?

Since this is an early-phase trial for BMS-984923, specific side effects are being studied but may include typical drug reactions like nausea, headaches, dizziness, or allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stage 1 Incidence of clinically significant changes in safety assessments

Stage 1 and Stage 2 Incidence of clinically significant lab abnormalities

Stage 1 and Stage 2 Incidence of treatment-emergent adverse events (TEAEs)

+1 more

Secondary study objectives

Stage 1 and Stage 2 Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by PK modeling

Stage 1 and Stage 2 Trough plasma drug concentration at steady state

Stage 2 Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale 14 Score range of 0-90, with higher scores indicating greater cognitive impairment.

+1 more

Side effects data

From 2022 Phase 1 trial • 36 Patients • NCT04805983

17%

Blood pressure increased

17%

Headache

17%

Blood triglycerides increased

100%

80%

60%

40%

20%

Study treatment Arm

10 mg BMS-984923

150 mg BMS-984923

40 mg BMS-984923

70 mg BMS-984923

100 mg BMS-984923

200 mg BMS-984923

Trial Design

11Treatment groups

Experimental Treatment

Placebo Group

Group I: 50 mg activeExperimental Treatment1 Intervention

BMS-984923 50 mg in healthy participants

Group II: 50 mg Active-ADExperimental Treatment1 Intervention

BMS-984923 50 mg

Group III: 150 mg Active 20dExperimental Treatment1 Intervention

BMS-984923 150 mg in healthy participants 20 days

Group IV: 100 mg Active-ADExperimental Treatment1 Intervention

BMS-984923 100 mg

Group V: 100 mg Active 20dExperimental Treatment1 Intervention

BMS-984923 100 mg in healthy participants 20 days

Group VI: 100 mg ActiveExperimental Treatment1 Intervention

BMS-984923 100 mg in healthy participants

Group VII: 150 mg Placebo 20dPlacebo Group1 Intervention

Placebo 150 mg in healthy participants 20 days

Group VIII: 100 mg Placebo 20dPlacebo Group1 Intervention

Placebo 100 mg in healthy participants 20 days

Group IX: 50 mg PlaceboPlacebo Group1 Intervention

Placebo 50 mg in healthy participants

Group X: 100 mg PlaceboPlacebo Group1 Intervention

Placebo 100 mg in healthy participants

Group XI: Placebo-ADPlacebo Group1 Intervention

Placebo matching

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-984923

2021

Completed Phase 1

~40

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors, NMDA receptor antagonists, and monoclonal antibodies targeting amyloid-beta. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) increase acetylcholine levels to improve cognitive function. NMDA receptor antagonists (e.g., memantine) regulate glutamate activity to prevent neuronal damage. Monoclonal antibodies (e.g., aducanumab) target and reduce amyloid-beta plaques. These treatments are vital as they aim to slow disease progression and alleviate symptoms, thereby enhancing the quality of life for AD patients.