Last updated on January 2019

Efficacy and Safety of AD-35 in Treatment of Subjects With Mild to Moderate Alzheimer's Disease

Brief description of study

multi-center, randomized, double-blind, parallel-group,placebo-controlled study to evaluate the safety and tolerability, efficacy, and PK of 60 mg and 90 mg AD-35 administered QD during 6 months of double-blind treatment followed by a second 6 months of open-label treatment to subjects with mild to moderate AD.

Detailed Study Description

Approximately 88 subjects are planned to be enrolled for the entire study. Initially, approximately 30 subjects will be randomized via a centralized interactive response technology (IRT) in a 1:2 ratio (ie, approximately 10 and 20 subjects) to receive placebo and 60 mg AD-35. The Data Safety Monitoring Board (DSMB) will review safety information after the first 30 subjects have completed the Day 30 Visit to confirm appropriateness of protocol-defined dosage modification.

If the average post-dose heart rate corrected QT interval using Fridericia's formula (QTcF) change from baseline is <15 msec for Day 15 and Day 30, and no more than 2 subjects have a QTcF change from baseline >30 msec, then, based on DSMB review, future subjects will be enrolled and will be randomized in a 1:1:3 ratio to receive placebo, 60 mg AD-35, and 90 mg AD-35, respectively.After the first 6 months of double-blind treatment, subjects on active study drug will remain on the current dose, and subjects assigned to placebo will receive 60 mg and 90 mg AD-35 in a 1:2 ratio, respectively, for an additional 6 months of open-label treatment.

Clinical Study Identifier: NCT03625401

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