Table 4.
Agents currently in phase I of Alzheimer's disease drug development (as of 1/30/2018)
| Agent | Agent mechanism class | Mechanism of action | Therapeutic purpose | Clinicaltrials.gov ID | Status | Sponsor | Start date | Estimated end date |
|---|---|---|---|---|---|---|---|---|
| Aducanumab | Anti-amyloid | Monoclonal antibody | Remove amyloid (DMT) | NCT01677572 | Active, not recruiting | Biogen | October-12 | October-19 |
| AGN-242071 | Undisclosed | Undisclosed | Undisclosed | NCT03316898 | Not yet recruiting | Allergan | November-17 | June-18 |
| Allopregnanolone injection | Metabolic, neuroprotective | GABA receptor modulator | Improve neurogenesis (cognitive enhancer) | NCT02221622 | Recruiting | University of Southern California, NIA | August-14 | December-17 |
| BIIB076 | Anti-tau | Monoclonal antibody | Remove tau (DMT) | NCT03056729 | Recruiting | Biogen | February-17 | April-19 |
| Bisnorcymserine (BNC) | Neurotransmitter based | Butyrylcholinesterase inhibitor | Acetylcholine neurotransmission (cognitive enhancer) | NCT01747213 | Recruiting | NIA | January-13 | July-18 |
| Crenezumab | Anti-amyloid | Monoclonal antibody | Remove amyloid (DMT) | NCT02353598 | Active, not recruiting | Genentech | February-15 | September-23 |
| hMSCs | Regenerative | Stem cell therapy | Regenerate neurons | NCT02600130 | Recruiting | Longeveron LLC | August-16 | October-19 |
| Idalopirdine (Lu AE58054) | Neurotransmitter based | 5-HT6 receptor antagonist | Improve neuronal signaling (cognitive enhancer) | NCT03307993 | Recruiting | H. Lundbeck A/S | September-17 | January-18 |
| Insulin aspart (Intranasal) | Metabolic | Increases insulin signaling in the brain | Enhance cell signaling and growth (cognitive enhancer) | NCT02462161 | Recruiting | Wake Forest School of Medicine, NIA, General Electric | May-15 | July-18 |
| JNJ-63733657 | Anti-tau | Monoclonal antibody | Remove tau (DMT) | NCT03375697 | Recruiting | Janssen | January-18 | February-19 |
| KHK6640 | Anti-amyloid | Anti-Aβ peptide antibody | Remove amyloid (DMT) | NCT03093519 | Active, not recruiting | Kyowa Hakko Kirin Co. | March-17 | June-18 |
| Lu AF20513 | Anti-amyloid | Polyclonal antibody | Remove amyloid (DMT) | NCT02388152 | Active, not recruiting | H. Lundbeck A/S | March-15 | October-18 |
| LY3002813 | Anti-amyloid | Monoclonal antibody | Remove amyloid (DMT) | NCT02624778 | Recruiting | Eli Lilly and Company | December-15 | June-20 |
| LY3303560 | Anti-tau | Monoclonal antibody | Remove tau (DMT) | NCT02754830 | Recruiting | Eli Lilly and Company | April-16 | April-18 |
| NCT03019536 | Recruiting | Eli Lilly and Company | January-17 | February-20 | ||||
| NDX-1017 | Regenerative | Hepatocyte growth factor | Regenerate neurons | NCT03298672 | Recruiting | M3 Biotechnology, ADDF, Biotrial Inc. | October-17 | June-18 |
| NP001 | Anti-inflammatory | Immune regulator of inflammatory monocytes/macrophages | Activate immune system (DMT) | NCT03179501 | Recruiting | Neuraltus Pharmaceuticals, University of Hawaii | September-17 | December-17 |
| NPT088 | Anti-amyloid, Anti-tau | IgG1 Fc-GAIM fusion protein | Clear amyloid and tau (DMT) | NCT03008161 | Recruiting | Proclara Biosciences | December-16 | December-18 |
| Oxaloacetate (OAA) | Metabolic | Mitochondrial enhancer | Enhance multiple cellular processes (DMT) | NCT02593318 | Recruiting | University of Kansas Medical Center | October-15 | October-18 |
| RGN1016 | Undisclosed | Undisclosed mechanism | Undisclosed | NCT02820155 | Recruiting | National Taiwan University | June-16 | February-17 |
| Salsalate | Anti-inflammatory | Non-steroidal anti-inflammatory | Reduce neuronal injury (DMT) | NCT03277573 | Recruiting | University of California, San Francisco | July-17 | October-18 |
| TAK-071 | Neurotransmitter based | Muscarinic M1 receptor modulator | Enhance acetylcholine neurotransmission (cognitive enhancer) | NCT02769065 | Recruiting | Takeda | May-16 | March-18 |
| Telmisartan | Neuroprotective, anti-inflammatory | Angiotensin II receptor blocker, PPAR-gamma agonist | Improve vascular functioning and effects on amyloid pathology (DMT) | NCT02471833 | Recruiting | Emory University | April-15 | March-18 |
| TPI-287 | Anti-tau | Microtubule protein modulator | Reduce tau-mediated cellular damage (DMT) | NCT01966666 | Active, not recruiting | University of California, San Francisco | November-13 | November-17 |
| Vorinostat | Neuroprotective | Histone deacetylase inhibitor | Enhance multiple cellular processes including tau aggregation and amyloid deposition (DMT) | NCT03056495 | Recruiting | German Center for Neurodegenerative Diseases, University Hospital, Bonn, University of Gottingen | September-17 | October-19 |
Abbreviations: ADDF, Alzheimer's Drug Discovery Foundation; BACE, Beta-site Amyloid precursor protein Cleaving Enzyme; DMT, disease-modifying therapy; GABA, gamma-aminobutyric acid; hMSCs, human mesenchymal stem cells; NIA, National Institute on Aging; PPAR, peroxisome proliferator-activated receptor.
NOTE. Twenty-three agents in 25 phase I clinical trials currently ongoing as of January 30, 2018 according to clinicaltrials.gov.
NOTE. Bolded terms represent new entries into the 2018 phase I pipeline.