Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02727699 | A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) | PHASE2 | COMPLETED | 185 | — | — | Mar 23, 2017 | Mar 15, 2019 | Feb 3, 2025 | 25 | United States, Australia +1 |
Change in Alzheimer's Disease Assessment Scales - Cognitive Subscale Score, version 14 (ADAS-Cog v14) Total scores of ADAS Cog 14 range from 0 to 90, with higher scores indicating greater disease severity.
Change in AD COMposite Scores (ADCOMs- ADCOMs, composite score is derived from a weighted linear combination of items from commonly used outcome scales Cognitive Subscale Version 14 \[ADAS-Cog v14\], Clinical Dementia Rating Scale - Sum of Boxes \[CDR-SOB\], and Mini-Mental Status Examination \[MMSE\]. Th ADCOMs range: 0 - 1.97, whereas a lover score is interpreted as a better result. Included scales: ADAS-Cog v14 (range: 0-90): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment. CDR-SOB (range: 0-18): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment. MMSE (range: 0-30): A higher score is indicative of better cognition, a lower score indicates higher cognitive impairment.
| Arm | Type | Description |
|---|---|---|
| Xanamem™ | EXPERIMENTAL | Oral Xanamem™ capsules 10mg, to be administered once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily |
| Name | Type | Description |
|---|---|---|
| Xanamem™ | DRUG | Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343 |
| Placebo (for Xanamem™) | DRUG | Excipient blend capsules manufactured to mimic Xanamem™ capsules |
Inclusion Criteria: 1. Males and females aged 50 years or older at the time of informed consent. 2. Female Subjects: 1. Post menopausal women, defined as no menses for 12 months without an alternative medical cause. If there is any concern about the menopausal status of a prospective female sub...