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ACTIVE NOT RECRUITING
NCT06125951
PHASE2/PHASE3

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

Sponsor: Actinogen Medical

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

247

Start Date

2024-04-12

Completion Date

2028-02

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

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.

Locations (35)

ACW Investigative Site 218

Carlsbad, California, United States

ACW Investigative Site 213

Orange, California, United States

ACW Investigative Site 209

Sherman Oaks, California, United States

ACW Investigative Site 211

Denver, Colorado, United States

ACW Investigative Site 208

Englewood, Colorado, United States

ACW Investigative Site 203

Delray Beach, Florida, United States

ACW Investigative site 201

Miami, Florida, United States

ACW Investigative site 202

New Port Richey, Florida, United States

ACW Investigative site 204

Orlando, Florida, United States

ACW Investigative site 205

The Villages, Florida, United States

ACW Investigative Site 207

Decatur, Georgia, United States

ACW Investigative Site 206

Toms River, New Jersey, United States

ACW Investigative Site 214

Albany, New York, United States

ACW Investigative Site 219

Staten Island, New York, United States

ACW Investigative Site 210

Dayton, Ohio, United States

ACW Investigative Site 217

Independence, Ohio, United States

ACW Investigative Site 212

Portland, Oregon, United States

ACW Investigative Site 216

East Providence, Rhode Island, United States

ACW Investigative Site 220

Austin, Texas, United States

ACW Investigative Site 215

Bellevue, Washington, United States

ACW Investigative Site 106

Darlinghurst, New South Wales, Australia

ACW Investigative Site 103

Erina, New South Wales, Australia

ACW Investigative Site 102

Kogarah, New South Wales, Australia

ACW Investigative Site 107

Macquarie Park, New South Wales, Australia

ACW Investigative Site 111

Newcastle, New South Wales, Australia

ACW Investigative Site 113

Birtinya, Queensland, Australia

ACW Investigative Site 105

Chermside, Queensland, Australia

ACW Investigative Site 114

Bedford Park, South Australia, Australia

ACW Investigative Site 110

Woodville South, South Australia, Australia

ACW Investigative Site 115

Carlton, Victoria, Australia

ACW Investigative Site 101

Ivanhoe, Victoria, Australia

ACW Investigative Site 108

Malvern, Victoria, Australia

ACW Investigative Site 112

Parkville, Victoria, Australia

ACW Investigative Site 104

Nedlands, Western Australia, Australia

ACW Investigative Site 109

West Perth, Western Australia, Australia