drugset / Trial / NCT02727699
A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu)
RandomizedParallel-groupTriple-blindTreatment
Summary
This XanADu Phase II study in mild Alzheimer's Disease (AD) is to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer's Disease. Subjects will be randomized to receive either 10mg once daily Xanamem or Placebo at a 1:1 ratio in a double-blinded fashion.
Timeline
- Start
- 2017-03-23
- Primary completion
- 2019-03-15
- Completion
- 2019-03-15
Publications
- Background Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25.
- Taylor J, Jaros M, Chen C, Harrison J, Hilt D. Plasma pTau181 Predicts Clinical Progression in a Phase 2 Randomized Controlled Trial of the 11beta-HSD1 Inhibitor Xanamem(R) for Mild Alzheimer's Disease. J Alzheimers Dis. 2024;100(1):139-150. doi: 10.3233/JAD-231456.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EMESTEDASTAT | Small molecule | 10 mg | Oral |