BMS-984923 for Alzheimer's Disease

No longer recruiting at 1 trial location

Overseen By Carol Gunnoud

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Allyx Therapeutics

Must be taking: Stable AD meds

Must not be taking: Psychoactive meds, Anticoagulants

Disqualifiers: Neurologic disease, Major depression, Uncontrolled diabetes, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BMS-984923, to determine its safety and tolerability in individuals with Alzheimer's disease and healthy older adults. The study examines different doses to understand the drug's effects on the body. Participants include those with memory problems due to Alzheimer's and healthy individuals over the age of 50 without memory issues. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, such as psychoactive drugs and those with potential drug interactions, at least 2 weeks before starting the study and during the trial. If you are on stable Alzheimer's medications like acetylcholinesterase inhibitors or memantine, you may continue them. Please consult with the trial team for specific guidance on your medications.

Is there any evidence suggesting that BMS-984923 is likely to be safe for humans?

Research has shown that BMS-984923 appears promising in early studies. Tests on older adults without memory problems found it to be safe, with no major side effects reported.

Currently, researchers are testing BMS-984923 in people with Alzheimer's and Parkinson’s diseases. This ongoing research indicates that the treatment is well-tolerated so far, though it remains early in the testing process.

As it is in an early phase of clinical trials, the main goal is to assess its safety and tolerability. While it seems safe in studies conducted so far, researchers continue to gather more information to confirm these findings. ^{1 2 3 4 5}

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

Researchers are excited about BMS-984923 for Alzheimer's disease because it represents a potential new approach in treating this challenging condition. While most current treatments, like cholinesterase inhibitors and NMDA receptor antagonists, focus on managing symptoms, BMS-984923 may offer a different mechanism by targeting underlying disease pathways. This could mean more effective treatment options that address the progression of Alzheimer's, not just its symptoms. If successful, BMS-984923 could provide hope for slowing down the disease, offering a significant advantage over existing therapies.

What evidence suggests that BMS-984923 might be an effective treatment for Alzheimer's Disease?

Research has shown that BMS-984923, which participants in this trial may receive, has potential in early studies for Alzheimer's disease. It improved memory and reduced brain cell damage in mice, which is important for brain health. This treatment targets harmful proteins called amyloid-beta oligomers, believed to significantly contribute to Alzheimer's. Earlier tests found BMS-984923 safe for older adults, even at different doses. These findings offer hope that it could aid memory and thinking in people with Alzheimer's. ^{1 3 4 6 7}

Who Is on the Research Team?

Adam Mecca, MD, PhD

Principal Investigator

Yale University

Stephanie Post, MD

Principal Investigator

Spaulding Clinical Research (Stage 1)

Adam Mecca, MD, PhD

Principal Investigator

Yale University (Stage 2)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

No history of cognitive impairment

Capable of providing written informed consent and willing to comply with all study requirements and procedures

I am between 50 and 80 years old.

Exclusion Criteria

Body mass index (BMI) >38 kg/m2 or body weight <50 kg

I do not have any serious or unstable health conditions.

Current nicotine use or positive urine cotinine test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

10 days of BID dosing in four ascending dose cohorts in healthy older adults

10 days

Stage 2 Treatment

BMS-984923 dosed BID for 28 days at two dose levels in participants with early Alzheimer's Disease

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-984923
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: 50 mg active Experimental Treatment 1 Intervention

BMS-984923 50 mg in healthy participants

Group II: 50 mg Active-AD Experimental Treatment 1 Intervention

BMS-984923 50 mg

Group III: 150 mg Active 20d Experimental Treatment 1 Intervention

BMS-984923 150 mg in healthy participants 20 days

Group IV: 100 mg Active-AD Experimental Treatment 1 Intervention

BMS-984923 100 mg

Group V: 100 mg Active 20d Experimental Treatment 1 Intervention

BMS-984923 100 mg in healthy participants 20 days

Group VI: 100 mg Active Experimental Treatment 1 Intervention

BMS-984923 100 mg in healthy participants

Group VII: 150 mg Placebo 20d Placebo Group 1 Intervention

Placebo 150 mg in healthy participants 20 days

Group VIII: 100 mg Placebo 20d Placebo Group 1 Intervention

Placebo 100 mg in healthy participants 20 days

Group IX: 50 mg Placebo Placebo Group 1 Intervention

Placebo 50 mg in healthy participants

Group X: 100 mg Placebo Placebo Group 1 Intervention

Placebo 100 mg in healthy participants

Group XI: Placebo-AD Placebo Group 1 Intervention

Placebo matching

Who Is Running the Clinical Trial?

Allyx Therapeutics

Lead Sponsor

Trials

4

Recruited

120+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/BMS-984923_%28ALX-001%29_UPDATE_%28drug_in_development%29.pdf

BMS-984923 (ALX-001) BMS-984923 restores cognitive deficits and synaptic loss in mouse models of Alzheimer's disease. Early phase clinical trials are currently ongoing.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05804383

Study Details | NCT05804383 | A Multiple Ascending Dose ... This research study will assess the safety and tolerability of multiple doses of BMS-984923 for the treatment of early Alzheimer's Disease (AD) and investigate ...

3. reporter.nih.gov reporter.nih.gov/search/RtR4yk7FC0-Eh8OWEZyIhg/project-details/10690672

Project Details - NIH RePORTER We plan to assess the safety and tolerability of BMS-984923 for the treatment of early Alzheimer's disease and investigate the use of synaptic density, measured ...

4. neurologylive.com neurologylive.com/view/alx001-advance-phase-2-studies-following-positive-phase-1b-mad-data

ALX001 to Advance to Phase 2 Studies Following Positive ... All told, the agent was safe in cognitively normal older adults at all doses investigated, and will be advanced into phase 2 studies of ...

5. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/BMS-984923-Cognitive-Vitality-For-Researchers.pdf

Amyloid-beta oligomer receptor inhibitors (BMS-984923) Neuroprotective Benefit: Preclinical data suggests that BMS-984823 may prevent Aβo- mediated toxicity without having effects on other aspects of Alzheimer's ( ...

6. allyxthera.com allyxthera.com/wp-content/uploads/2024/03/ALLYX_ADPDPresentation_9MAR_Final.pdf

A Phase 1b Multiple Ascending Dose Study Of The Safety, ... ALX-001 is advancing into Phase 2 development in both Alzheimer's and Parkinson's disease. • ALX-001 was safe in cognitively normal older adults ...

7. ddw-online.com ddw-online.com/early-trial-data-supports-neurodegenerative-disease-modifying-drug-28941-202403/

Trial supports neurodegenerative disease-modifying drug Allyx Therapeutics has initiated a 28-day safety study of ALX-001 in Alzheimer's disease patients and is initiating a study in Parkinson's ...