clinical trial · NCT04947553
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
Agitation in Patients With Dementia of the Alzheimer's TypeAlzheimer DiseaseAgitation, PsychomotorAXS-05 (dextromethorphan-bupropion)Placebo
brief summary
This study will evaluate the long-term safety and efficacy of AXS-05 in subjects with Alzheimer's disease (AD) agitation.
started
Jun 17, 2021
primary completion
Dec 3, 2024
completion
Dec 21, 2024
last updated
Dec 8, 2025
detailed description
This study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. Subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive AXS-05 or switch to placebo, for up to 24 weeks.
official title
An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Dementia of the Alzheimer's Type
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol