Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers

Status unconfirmed · Phase 1

Conditions studied: Alzheimer Disease, Dementia

In brief

This project is developing a novel disease-modifying compound for Alzheimer's disease (AD).

Key facts

Study ID

NCT05817643

Run by

Allyx Therapeutics

People needed

12

Starts

2023-01-10

Expected to finish

2024-11-15

Last updated by the study team

2024-07-30

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or women between the ages of 50 and 80 years, inclusive
• No history of cognitive impairment
• Capable of providing written informed consent and willing to comply with all study requirements and procedures
• Participant is not pregnant, lactating, or of childbearing potential

You may not qualify if…

• Body mass index (BMI) >38 kg/m2 or body weight <50 kg.
• Significant cerebrovascular disease
• Any significant neurologic disease
• A current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) diagnosis of active major depression, schizophrenia or bipolar disorder
• Clinically significant or unstable medical condition
• Any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs
• History of cholecystectomy
• History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C virus [HCV] antibody).
• Use of psychoactive medications
• Use of medications with potential drug-drug interactions
• Use of another investigational agent
• Clinically significant abnormalities in screening laboratories
• Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale
• Acceptable Geriatric Depression Scale (GDS) score

Where it is running

• Spaulding Clinical Research — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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