Alzheimer's drug-development pipeline: 2016.

BACKGROUND: Alzheimer's disease (AD) is growing in frequency and new therapies are urgently needed. METHODS: We assessed clinicaltrials.gov (accessed 1-4-2016) to determine the number and characteristics of trials in phase I, phase II, and phase III for treatment of AD. RESULTS: There are currently 24 agents in 36 trials in phase III of AD drug development. Seven of these 24 agents are symptomatic cognitive-enhancing compounds, and 17 are disease-modifying treatments (DMTs). Most DMTs address amyloid-related targets (76%). There are 45 agents in phase II being assessed in 52 clinical trials. Phase II trials include 30 DMTs, with 26 small molecules and 4 immunotherapies. There are 24 agents in the first phase of AD drug development. DISCUSSION: Amyloid is the principal target of late-stage development programs. There are relatively few agents in clinical trials for AD suggesting a need to amplify the drug discovery ecosystem.