NCT05804383

A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease

A Phase 1B Multiple Ascending Dose Study of The Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients With Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Allyx Therapeutics · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b Multiple Ascending Dose Study of the Safety and Tolerability of BMS-984923 in Healthy Older Adults and Patients with Alzheimer's Disease

Detailed description

This double-blind placebo-controlled study will be completed in 2 stages. The first stage will evaluate 10-days of BID dosing in four ascending dose cohorts in healthy older adults and Stage 2 will examine BMS-984923 dosed BID for 28 days at two dose levels in comparison to Placebo in participants with early AD. 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 the use of synaptic density, measured with positron emission tomography (PET), as an early marker of therapeutic response to treatments that target synapse restoration.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	BMS-984923	Capsules
DRUG	Placebo	Capsules

Timeline

• Start date: 2023-03-28
• Primary completion: 2025-07-15
• Completion: 2025-10-15
• First posted: 2023-04-07
• Last updated: 2025-11-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study