NCT04983368

A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers

XanaMIA-DR a Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Pharmacodynamics and Safety of Xanamem® in Healthy Elderly Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Actinogen Medical · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Xanamem® is being developed as a potential drug for Mild Cognitive Impairment in Alzheimer's disease. This study drug has been designed to change the cortisol levels in the brain. Cortisol is a naturally occurring hormone in the body. It is believed that reducing the level of cortisol will be a benefit in the treatment of Mild Cognitive Impairment in Alzheimer's disease. The purpose of this study in older volunteers is to investigate the smallest dose of Xanamem® (5 mg or 10 mg) which works and to investigate which dose in this study will be used in the upcoming clinical trials in patients.

Conditions

• Mild Cognitive Impairment
• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Xanamem® 5 mg	Oral Xanamem® ("UE2343") capsules 5 mg, administered orally once daily.
DRUG	Placebo	Matching placebo which is identical in appearance to the test product (5 mg, 10 mg Xanamem® QD) except that it contains no active ingredient.
DRUG	Xanamem® 10 mg	Oral Xanamem® ("UE2343") capsules 10 mg, administered orally once daily.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-02-11
• Completion: 2022-02-11
• First posted: 2021-07-30
• Last updated: 2025-01-23

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study