Oral Tau Aggregation Inhibitor for Alzheimer’s Disease: Design, Progress and Basis for Selection of the 16 mg/day Dose in a Phase 3, Randomized, Placebo-Controlled Trial of Hydromethylthionine Mesylate

ABSTRACT:

Background

Hydromethylthionine mesylate is a tau aggregation inhibitor shown to have exposure-dependent pharmacological activity on cognitive decline and brain atrophy in two completed Phase 3 trials in mild/moderate Alzheimer’s disease (AD).

Objectives

The present report summarises the basis for selection of 16 mg/day as monotherapy as the optimal treatment regime and the design rationale of a confirmatory Phase 3 trial (LUCIDITY).

Design

The trial comprises a 12-month double-blind, placebo-controlled phase followed by a 12-month modified delayed-start open-label treatment phase.

Setting

76 clinical research sites in North America and Europe.

Participants

545 patients with probable AD or MCI-AD in the final version of the protocol.

Interven

SUBMITTER: Wischik C 

PROVIDER: S-EPMC9226274 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature