A Phase 3 Clinical Trial Protocol to Evaluate the Efficacy and Safety of NA‐831 in Subjects with Early Onset of Alzheimer’s Disease

Abstract

AbstractBackgroundThis phase 3 study consists of a Core and Open Label Extension (OLE) Phase in 465 participants with Early Alzheimer’s Disease (EAD), and is being conducted to evaluate the efficacy and safety of NA‐ 831. The Core is a 52‐week treatment, multicenter, double blind, placebo controlled parallel group study.MethodCore Study: Participants will receive one capsule of 30 milligram (mg) NA‐831 orally once a day in the morning. The core study will be double blinded. Placebo Comparator: The core study will be double blinded. Experimental: Open Label Extension Phase: Participants completing the core study will receive one 30 milligram (mg) NA‐31 capsule orally once a day in the morning.ResultKey Outcome Measures:1. Core Study: Change from Baseline in the Clinical Dementia Rating and Sum of Boxes (CDR‐SB) Score at 48 Weeks [ Time Frame: Baseline, Week 52]2.Open‐Label Extension Phase: Number of Participants With Treatment‐Emergent Adverse Events (AEs) [ Time Frame: Up to Week 52 of Extension Phase] Secondary Outcome Measures: Cognition‐13 (ADAS‐Cog‐13) at Weeks 24, 52 [ Time Frame: Baseline, Week 24, Week 52 of Extension Phase] CORE STUDY: Mild cognitive impairment due to AD or mild AD dementia including 1. MMSE score equal to or greater than 243. CDR global score of 0.5 3. CDR Memory Box score of 0.5 or greaterConclusionThe Phase 3 clinical trial of NA‐831 is being conducted in multicenters in the US and several countries. The details of the Phase 3 methodology and protocol will be presented and discussed.