NCT05657691

Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)

XanaCIDD: A Double-Blind, Randomized, Placebo Controlled, Parallel-Group Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Actinogen Medical · Industry
• Sex: All
• Age: 18 Years – 75 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 XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.

Conditions

• Major Depressive Disorder
• MDD
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Xanamem™	Xanamem™ is formulated in green and cream-colored size 3, Coni-Snap-shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains the active pharmaceutical ingredient of UE2343.
DRUG	Placebo	Matching placebo which is identical in appearance to the test product (10 mg Xanamem™ QD) except that it contains no active ingredient.

Timeline

• Start date: 2022-11-28
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2022-12-20
• Last updated: 2025-01-22

Locations

12 sites across 2 countries: Australia, United Kingdom