A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects With Dementia of the Alzheimer's Type
Phase of Trial: Phase II/III
Latest Information Update: 27 Jul 2017
At a glance
- Drugs Bupropion/dextromethorphan (Primary)
- Indications Agitation; Alzheimer's disease
- Focus Therapeutic Use
- Acronyms ADvance; ADVANCE-1
- Sponsors Axsome Therapeutics
- 24 Jul 2017 Planned End Date changed from 1 Jul 2020 to 1 Sep 2019.
- 24 Jul 2017 Planned primary completion date changed from 1 Jun 2020 to 1 Aug 2019.
- 17 Jul 2017 According to an Axsome Therapeutics media release, this trial incorporates a planned interim analysis by an independent data monitoring committee to assess the assumptions used to determine the sample size of the trial.