ALZHEIMER THERAPEUTICS: POTENTIAL PIPELINE PREDICTIONS
- Jeffrey L. Cummings, United States of America
Abstract
Aims
Alzheimer’s disease (AD) has a complex biology with many potential processes that might comprise targets for therapy.
Methods
We reviewed clinicaltrials.gov the US Food and Drug Administration (FDA) database to determine the number of agents in all phases of the AD drug development pipeline as reflected in this registry. We use the NIH Common AD Research Ontology (CADRO) categories to determine the targets and therapeutic categories of the agents in trials.
Results
There are currently (of as of 2/27/2020) 121 unique agents in trials; 29 in Phase 3, 65 in Phase 2, and 27 in Phase 3. Amyloid-beta protein and hyperphosphorylated tau protein are important therapeutic targets --- 16 and 11 agents in the pipeline respectively --- and account for a major portion of the drugs in the AD pipeline. Neuroinflammation/inflection (20 agents) and synaptic plasticity/neuroprotection (20 agents) have the largest number of agents in trials across Phase 1, Phase 2, and Phase 3 trials. Metabolic/bioenergetic agents are being assessed in Phase 2 (6 agents) and Phase 1 (3 agents) trials. Eighty percent of the agents in the pipeline (97 of 121) are putative disease modifying drugs; 10% target cognitive enhancement and 10% address neuropsychiatric manifestations of AD. Of the total number of trials for drugs in the pipeline, 6 are in preclinical AD, 39 are in prodromal AD, and 45 are in AD dementia.
Conclusions
The AD drug development pipeline is beginning to deliver drugs that address important unmet needs of patients with AD or those at risk for the disease.