Phase 2/3Active, not recruitingAge-related condition
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease (XanaMIA)
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
- Sponsor
- Actinogen Medical (Industry)
- Enrolment
- 247 enrolled
- Conditions
- Dementia Moderate; Dementia, Mild; Alzheimer Disease
- Interventions
- Xanamem; Placebo
- Ages
- adults, older adults
- Registry
- NCT06125951
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Effects of 10 mg Xanamem on integrated cognitive and functional abilities
- Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]
History
Study completion expected
Last registry update
Primary completion
Started
Registered