Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients

Summary

The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.

Timeline

Start

2015-10

Primary completion

2018-08

Completion

2018-08

Publications

• Yu HJ, Dickson SP, Wang PN, Chiu MJ, Huang CC, Chang CC, Liu H, Hendrix SB, Dodart JC, Verma A, Wang CY, Cummings J. Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study. EBioMedicine. 2023 Aug;94:104665. doi: 10.1016/j.ebiom.2023.104665. Epub 2023 Jun 29.
• Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun.

Drugs

Indications