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Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Sponsor: Actinogen Medical
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
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.
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