Table 1.
Agents currently in phase III of Alzheimer's disease drug development (as of January 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) | NCT02484547 | Recruiting | Biogen | September-15 | April-22 |
| NCT02477800 | Recruiting | Biogen | August-15 | March-22 | ||||
| Albumin + immunoglobulin | Anti-amyloid | Polyclonal antibody | Remove amyloid (DMT) | NCT01561053∗ | Active, not recruiting | Grifols | March-12 | December-17 |
| ALZT-OP1a + ALZT-OP1b (cromolyn + ibuprofen) | Anti-amyloid, anti-inflammatory | Mast cell stabilizer (cromolyn), anti-inflammatory (ibuprofen) | Reduce neuronal damage; mast cells may also play a role in amyloid pathology (DMT) | NCT02547818 | Recruiting | AZTherapies, Pharma Consulting Group, KCAS Bio, APCER Life Sciences | September-15 | November-19 |
| AVP-786 | Neurotransmitter based | Sigma 1 receptor agonist; NMDA receptor antagonist | Improve neuropsychiatric symptoms (agitation) | NCT02442765 | Recruiting | Avanir | September-15 | July-18 |
| NCT02446132 | Recruiting-EXT | Avanir | December-15 | March-21 | ||||
| AZD3293 (LY3314814) | Anti-amyloid | BACE1 inhibitor | Reduce amyloid production (DMT) | NCT02245737∗ | Active, not recruiting | AstraZeneca, Eli Lilly | September-14 | September-19 |
| NCT02783573 | Recruiting | AstraZeneca, Eli Lilly | July-16 | March-21 | ||||
| NCT02972658 | Recruiting-EXT | AstraZeneca, Eli Lilly | March-17 | September-20 | ||||
| AXS-05 | Neurotransmitter based | Sigma 1 receptor agonist; NMDA receptor antagonist (dextromethorphan); serotonin norepinephrine reuptake inhibition (bupropion) | Improve neuropsychiatric symptoms (agitation) | NCT03226522 | Recruiting | Axsome Therapeutics | July-17 | September-19 |
| CAD106 & CNP520 | Anti-amyloid | Amyloid vaccine, BACE inhibitor | Remove/reduce amyloid (DMT) | NCT02565511∗ | Recruiting | Novartis, Amgen, NIA, Alzheimer's Association, Banner Alzheimer's Institute | November-15 | May-24 |
| CNP520 | Anti-amyloid | BACE Inhibitor | Reduce amyloid production (DMT) | NCT03131453 | Recruiting | Novartis, Amgen, Banner Alzheimer's Institute | August-17 | July-24 |
| Crenezumab | Anti-amyloid | Monoclonal antibody | Remove amyloid (DMT) | NCT02670083 | Active, not recruiting | Roche/Genentech | March-16 | July-21 |
| NCT03114657 | Recruiting | Roche/Genentech | March-17 | October-22 | ||||
| E2609 (elenbecestat) | Anti-amyloid | BACE inhibitor | Reduce amyloid production (DMT) | NCT02956486 | Recruiting | Eisai, Biogen | October-16 | December-20 |
| NCT03036280 | Recruiting | Eisai, Biogen | December-16 | December-20 | ||||
| Escitalopram | Neurotransmitter based | Serotonin reuptake inhibition | Improve neuropsychiatric symptoms (agitation) | NCT03108846 | Not yet recruiting | NIA, JHSPH Center for Clinical Trials | September-17 | March-21 |
| Gantenerumab | Anti-amyloid | Monoclonal antibody | Remove amyloid (DMT) | NCT02051608 | Active, not recruiting | Roche | March-14 | November-19 |
| NCT01224106 | Active, not recruiting | Roche | November-10 | July-20 | ||||
| Gantenerumab and solanezumab and JNJ-54861911 | Anti-amyloid | Monoclonal antibody, BACE inhibitor | Remove amyloid/reduce amyloid production (DMT) | NCT01760005∗ | Recruiting | Washington University, Eli Lilly, Roche, NIA, Alzheimer's Association | December-12 | December-23 |
| Icosapent ethyl (IPE) | Neuroprotective | Purified form of the omega-3 fatty acid EPA | Protect neurons from disease pathology | NCT02719327∗ | Recruiting | VA Office of Research and Development, University of Wisconsin, Madison | December-16 | November-21 |
| Insulin intranasal (Humulin) | Metabolic | Replace insulin in the brain | Enhance cell signaling and neurogenesis (cognitive enhancer) | NCT01767909∗ | Active, not recruiting | University of Southern California, NIA, ATRI, Wake Forest University | January-14 | December-18 |
| ITI-007 | Neurotransmitter based | 5-HT2A antagonist, dopamine receptor modulator | Improve neuropsychiatric symptoms (agitation) | NCT02817906 | Recruiting | Intra-Cellular Therapies, Inc. | June-16 | August-18 |
| JNJ-54861911 | Anti-amyloid | BACE inhibitor | Reduce amyloid production (DMT) | NCT02569398∗ | Recruiting | Janssen | November-15 | April-24 |
| Methylphenidate | Neurotransmitter based | Dopamine reuptake inhibitor | Improve neuropsychiatric symptoms (apathy) | NCT02346201 | Recruiting | Johns Hopkins, NIA | January-16 | August-20 |
| MK-8931 (verubecestat) | Anti-amyloid | BACE inhibitor | Reduce amyloid production (DMT) | NCT01953601 | Active, not recruiting | Merck | November-13 | March-21 |
| MK-4305 (suvorexant) | Neurotransmitter based | Dual orexin receptor antagonist | Improve neuropsychiatric symptoms (sleep disorders) | NCT02750306 | Recruiting | Merck | May-16 | April-18 |
| Nabilone | Neurotransmitter based | Cannabinoid (receptor agent) | Improve neuropsychiatric symptoms (agitation) | NCT02351882∗ | Recruiting | Sunnybrook Health Sciences Centre | January-15 | January-18 |
| Octohydroaminoacridine succinate | Neurotransmitter based | Acetylcholinesterase inhibitor | Improve acetylcholine signaling (cognitive enhancer) | NCT03283059 | Recruiting | Shanghai Mental Health Center, Changchun-Huayang High-tech Co., Jiangsu Sheneryang High-tech Co. | August-17 | February-20 |
| GV-971 (Sodium Oligo-mannurarate) | Anti-amyloid | Inhibit amyloid aggregation | Remove amyloid plaque load (DMT) | NCT02293915 | Recruiting | Shanghai Green valley Pharmaceutical | April-14 | September-18 |
| Solanezumab | Anti-amyloid | Monoclonal antibody | Remove amyloid (DMT) | NCT02008357 | Active, not recruiting | Eli Lilly, ATRI | February-14 | July-22 |
| TRx0237 (LMTX) | Anti-tau | Tau protein aggregation inhibitor | Reduce tau-mediated neuronal damager (DMT) | NCT02245568 | Recruiting, Extension | TauRx Therapeutics | August-14 | September-17 |
| TTP488 (azeliragon) | Anti-amyloid, anti-inflammatory | RAGE antagonist | Reduce amyloid uptake in brain and lower inflammation in glial cells (DMT/cognitive enhancer) | NCT02080364 | Active, not recruiting | vTv Therapeutics | April-15 | January-19 |
| NCT02916056 | Recruiting – EXT | December-16 | November-20 | |||||
| Zolpidem | Neurotransmitter based | Positive allosteric modulator of GABA-A receptors | Improve neuropsychiatric symptoms (sleep disorders) | NCT03075241 | Recruiting | Brasilia University Hospital | October-16 | December-18 |
Abbreviations: ATRI, Alzheimer's Therapeutic Research Institute; BACE, Beta-site Amyloid precursor protein Cleaving Enzyme; DMT, disease-modifying therapy; EPA, eicosapentaenoic acid; GABA, gamma-aminobutyric acid; NIA, National Institute on Aging; RAGE, receptor for advanced glycation end products.
NOTE. Twenty-six agents in 35 phase III clinical trials currently ongoing as of January 30, 2018 according to clinicaltrials.gov.
NOTE. Bolded terms represent new entries into the 2018 phase III pipeline.
∗
Phase II/III trials.