drugset / Trial / NCT03533257
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
Phase 2
Completed
95 enrolled
Amylyx Pharmaceuticals Inc.
Alzheimer's Association · collabAlzheimer's Drug Discovery Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
Timeline
- Start
- 2018-09-14
- Primary completion
- 2020-10-22
- Completion
- 2020-11-06
Publications
- Results Arnold SE, Hendrix S, Nicodemus-Johnson J, Knowlton N, Williams VJ, Burns JM, Crane M, McManus AJ, Vaishnavi SN, Arvanitakis Z, Neugroschl J, Bell K, Trombetta BA, Carlyle BC, Kivisakk P, Dodge HH, Tanzi RE, Yeramian PD, Leslie K. Biological effects of sodium phenylbutyrate and taurursodiol in Alzheimer's disease. Alzheimers Dement (N Y). 2024 Aug 9;10(3):e12487. doi: 10.1002/trc2.12487. eCollection 2024 Jul-Sep.
- Wen ZQ, Lin J, Xie WQ, Shan YH, Zhen GH, Li YS. Insights into the underlying pathogenesis and therapeutic potential of endoplasmic reticulum stress in degenerative musculoskeletal diseases. Mil Med Res. 2023 Nov 9;10(1):54. doi: 10.1186/s40779-023-00485-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Phenylbutyrate | Small molecule | 3 g | Oral |
| Comparator | Taurursodiol | Small molecule | 1 g | Oral |