Title

Intepirdine as Adjunctive Therapy to Donepezil for Mild-To-Moderate Alzheimer’s Disease: A Randomized, Placebo-Controlled, Phase 3 Clinical Trial (Mindset)

Document Type

Article

Publication Date

3-17-2021

Publication Title

Alzheimer's & Dementia: Translational Research and Clinical Interventions

Volume

7

Issue

1

Abstract

Introduction: A previous phase 2b study supported the use of the 5-HT6 receptor antagonist intepirdine as adjunctive therapy to donepezil for Alzheimer's disease (AD) dementia. A phase 3 study, MINDSET, was performed to test this hypothesis. Methods: MINDSET was a global, double-blind, randomized, placebo-controlled trial in 1315 mild-to-moderate AD dementia patients on stable donepezil. Patients received 35 mg/day intepirdine or placebo for 24 weeks. The co-primary endpoints were change from baseline to week 24 on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). Results: There were no statistically significant differences between intepirdine and placebo groups (adjusted mean [95% confidence interval]) on the co-primary endpoints ADAS-Cog (−0.36 [−0.95, 0.22], P = 0.2249) and ADCS-ADL (−0.09 [−0.90, 0.72], P = 0.8260). Intepirdine demonstrated a favorable safety profile similar to placebo. Discussion: Intepirdine as adjunctive therapy to donepezil did not produce statistical improvement over placebo on cognition or activities of daily living in mild-to-moderate AD dementia patients.

Keywords

5-HT6; Alzheimer's disease; Clinical trial; Intepirdine; Phase 3

Disciplines

Nervous System Diseases | Neuroscience and Neurobiology

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