BMS-984923 for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Carol Gunnoud

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Allyx Therapeutics

Must be taking: Stable AD meds

Must not be taking: Psychoactive meds, Anticoagulants

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

Trial Summary

What is the purpose of this trial?

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.

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.

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)

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• BMS-984923 (Other)
• Placebo (Drug)

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.

Participant Groups

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+