NCT06125951

Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

A Phase 2b/3, Double-Blind, Placebo-Controlled, Parallel-Group, 36-Week, 2-Arm Trial With an Open-Label Extension Phase to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Actinogen Medical · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD). This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.

Conditions

• Dementia Moderate
• Dementia, Mild
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Xanamem	Xanamem drug product is formulated as an immediate-release film-coated tablet formulation for oral administration. Each Xanamem tablet contains 10 mg Xanamem (UE2343) drug substance and excipients.
DRUG	Placebo	Matching placebo which is identical in appearance to the test product (10 mg Xanamem once daily) except that it contains no active ingredient.

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-10-01
• Completion: 2028-02-01
• First posted: 2023-11-09
• Last updated: 2026-02-18

Locations

35 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study