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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
247
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.
Matching placebo which is identical in appearance to the test product (10 mg Xanamem once daily) except that it contains no active ingredient.
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
Effects of 10 mg Xanamem on integrated cognitive and functional abilities
Change from Baseline to end of treatment (EOT) in the Clinical Dementia Ratio - Sum of Boxes (CDR-SB). The CDR-SB is calculated as an average score, with lower scores indicating improvement.
Time frame: 36 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]
Incidence and severity of TEAEs
Time frame: 36 weeks
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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
...and 25 more locations