A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: PlaceboDrug: BMS-984923
- Registration Number
- NCT05804383
- Lead Sponsor
- Allyx Therapeutics
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo-AD Placebo Placebo matching 100 mg Placebo Placebo Placebo 100 mg in healthy participants 150 mg Placebo 20d Placebo Placebo 150 mg in healthy participants 20 days 100 mg Placebo 20d Placebo Placebo 100 mg in healthy participants 20 days 50 mg active BMS-984923 BMS-984923 50 mg in healthy participants 50 mg Placebo Placebo Placebo 50 mg in healthy participants 100 mg Active 20d BMS-984923 BMS-984923 100 mg in healthy participants 20 days 100 mg Active BMS-984923 BMS-984923 100 mg in healthy participants 150 mg Active 20d BMS-984923 BMS-984923 150 mg in healthy participants 20 days 50 mg Active-AD BMS-984923 BMS-984923 50 mg 100 mg Active-AD BMS-984923 BMS-984923 100 mg
- Primary Outcome Measures
Name Time Method Stage 1 and Stage 2 Incidence of clinically significant lab abnormalities Up to 10 days after last dose Safety
Stage 1 and Stage 2 Incidence of treatment-emergent adverse events (TEAEs) Up to 10 days after last dose Safety
Stage 1 Incidence of clinically significant changes in safety assessments Up to 10 days after last dose Vital signs, physical exam, electrocardiogram \[ECG\], Neuropsychiatric Inventory-Questionnaire \[NPI Q\], Geriatric Depression Scale \[GDS\], Glasgow Coma Scale \[GCS\], Montreal Cognitive Assessment \[MOCA\])
Stage 2 Incidence of clinically significant changes in safety assessments Up to 10 days after last dose Vital signs, physical exam, ECG, NPI Q, GDS, MOCA, and Functional Assessment Questionnaire \[FAQ\])
- Secondary Outcome Measures
Name Time Method Stage 1 and Stage 2 Trough plasma drug concentration at steady state Up to 10 days after last dose plasma concentration as determined by pharmacokinetic modeling
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 Up to 10 days after last dose Total plasma concentration as determined by pharmacokinetic modeling
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. Up to 7 days after the last dose Assessment of cognitive impairment.
Stage 2 Change from baseline in synaptic density PET Up to 24 hours after last dose Pharmacodynamics
Trial Locations
- Locations (2)
Spaulding Clinical Research
🇺🇸West Bend, Wisconsin, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Related News
Allyx Therapeutics Awarded $3.3 Million NIH Grant to - GlobeNewswire
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