Table 2.
Agents currently in phase II of Alzheimer's disease drug development (as of 1/5/2017)
| Agent | Agent mechanism class | Mechanism of Action | Clinicaltrials.gov identifier | Status | Sponsor | Start date | Estimated end date |
|---|---|---|---|---|---|---|---|
| AADvac1 | Anti-tau | Monoclonal antibody | NCT02579252 | Recruiting | Axon Neuroscience | Dec-15 | Feb-19 |
| ABBV-8E12 | Anti-tau | Monoclonal antibody | NCT02880956 | Recruiting | AbbVie | Oct-16 | Mar-21 |
| ATP | Anti-amyloid | Inhibits amyloid misfolding and toxicity | NCT02279511 | Active, not recruiting | Fundació Clínic per la Recerca Biomèdica, Spain | Nov-14 | Nov-16 |
| AD-SVF cells | Regenerative | AD-SVF cell infusion | NCT02912169∗ | Recruiting | Ageless Regenerative Institute | Nov-15 | Dec-17 |
| ANAVEX 2-73 | Neuroprotective | Sigma-1 receptor agonist | NCT02244541 | Active, not recruiting | Anavex Life Sciences | Dec-14 | Oct-16 |
| NCT02756858 | Recruiting, extension | Mar-16 | Nov-18 | ||||
| Atomoxetine | Anti-amyloid | Adrenergic uptake inhibitor, SNRI | NCT01522404 | Active, not recruiting | Emory University, NIA | Mar-12 | Dec-17 |
| AVP-786 | Neurotransmitter based | Mixed transmitter effect | NCT02534038 | Recruiting | Avanir | Oct-15 | Mar-18 |
| AZD0530 (saracatinib) | Anti-amyloid | Kinase inhibitor | NCT02167256 | Active, not recruiting | Yale University, ATRI, AstraZeneca | Dec-14 | Dec-17 |
| BAC | Undisclosed | Undisclosed mechanism | NCT02886494 | Not yet recruiting | Charsire Biotechnology | Nov-16 | Nov-19 |
| NCT02467413 | Not yet recruiting | Charsire Biotechnology, A2 Healthcare Taiwan Corporation | Mar-16 | Dec-17 | |||
| BAN2401 | Anti-amyloid | Monoclonal antibody | NCT01767311 | Recruiting | Eisai | Dec-12 | Jul-18 |
| Benfotiamine | Metabolic | Antioxidant | NCT02292238 | Recruiting | Burke Medical Research Institute, Columbia University, NIA, ADDF | Nov-14 | Nov-19 |
| BI409306 | Neuroprotective | Phosphodiesterase 9A inhibitor | NCT02240693 | Recruiting | Boehringer Ingelheim | Jan-15 | Oct-17 |
| NCT02337907 | Recruiting | Boehringer Ingelheim | Jan-15 | Oct-17 | |||
| Bryostatin 1 | Neuroprotective | Protein kinase C modulator | NCT02431468 | Active, not recruiting | Neurotrope Bioscience | Jul-15 | May-17 |
| Candesartan | Neuroprotective, anti-inflammatory | Angiotensin receptor blocker | NCT02646982 | Recruiting | Emory University | Jun-16 | Sep-21 |
| CB-AC-02 (Placenta derived-MSCs) | Regenerative | Stem cell therapy | NCT02899091∗ | Not yet recruiting | CHA Biotech Co. | Sep-16 | Jun-18 |
| Cilostazol | Neuroprotective | Phosphodiesterase 3 antagonist | NCT02491268 | Recruiting | National Cerebral and Cardiovascular Center, Japan | Jul-15 | Jul-18 |
| CPC-201 | Neuroprotective | Cholinesterase inhibitor + peripheral cholinergic antagonist | NCT02549196 | Recruiting | Chase Pharmaceuticals | Oct-15 | Dec-16 |
| NCT02434666 | Active, not recruiting, Extension | Chase Pharmaceuticals | Jan-15 | Dec-16 | |||
| NCT02860065 | Not yet recruiting | Chase Pharmaceuticals | Sep-16 | Jun-17 | |||
| Crenezumab | Anti-amyloid | Monoclonal antibody | NCT01998841 | Recruiting | Genentech, NIA, Banner Alzheimer's Institute | Dec-13 | Sep-20 |
| CT1812 | Anti-amyloid | Sigma-2 receptor modulator | NCT02907567∗ | Recruiting | Cognition Therapeutics | Sep-16 | May-17 |
| DAOIB | Neurotransmitter based | NMDA enhancer | NCT02103673 | Recruiting | Chang Gung Memorial Hospital, Taiwan | Feb-14 | Sep-17 |
| NCT02239003 | Recruiting | Chang Gung Memorial Hospital, Taiwan | Jan-12 | Dec-17 | |||
| Dronabinol | Neurotransmitter based | CB1 and CB2 endocannabinoid receptor partial agonist | NCT02792257 | Not yet recruiting | Mclean Hospital, Johns Hopkins University | Aug-16 | Dec-20 |
| E2609 | Anti-amyloid | BACE inhibitor | NCT02322021 | Recruiting | Eisai, Biogen | Nov-14 | Jan-18 |
| Formoterol | Neuroprotective, anti-inflammatory | β-2 adrenergic receptor agonist | NCT02500784 | Recruiting | Palo Alto Veterans Institute for Research, Mylan, Alzheimer's Association | Jan-15 | Jul-16 |
| hUCB-MSCs | Regenerative | Stem cell therapy | NCT02054208∗ | Recruiting | Medipost | Feb-14 | Feb-18 |
| NCT01547689∗ | Active, not recruiting | Affiliated Hospital to Academy of Military Medical Sciences, China | Mar-12 | Dec-16 | |||
| NCT02513706 | Not yet recruiting | South China Research Center | May-16 | Oct-19 | |||
| NCT02672306∗ | Not yet recruiting | South China Research Center | May-16 | Oct-19 | |||
| NCT02833792 | Recruiting | Stemedica Cell Technologies | Jun-16 | Jun-18 | |||
| Insulin detemir (intranasal) | Metabolic | Increases insulin signaling in the brain | NCT01595646 | Active, not recruiting | Wake Forest School of Medicine, Alzheimer's Association | Nov-11 | Mar-17 |
| Insulin glulisine | Metabolic | Increases insulin signaling in the brain | NCT02503501 | Recruiting | HealthPartners Institute | Aug-15 | Sep-17 |
| JNJ-54861911 | Anti-amyloid | BACE inhibitor | NCT02406027 | Active, not recruiting, Extension | Janssen | Jul-15 | Oct-22 |
| Levetiracetam | Neurotransmitter based | Anticonvulsant | NCT02002819 | Recruiting | University of California, San Francisco | Jun-14 | Dec-17 |
| Liraglutide | Metabolic | Glucagon-like peptide 1 receptor agonist | NCT01843075 | Recruiting | Imperial College London | Jan-14 | Mar-19 |
| Lithium | Neurotransmitter based | Ion channel modulator | NCT02129348 | Recruiting | New York State Psychiatric Institute, NIA | Jun-14 | Apr-19 |
| LY3202626 | Anti-amyloid | BACE Inhibitor | NCT02791191 | Recruiting | Eli Lilly | Jun-16 | Aug-18 |
| Methylene blue | Anti-tau | Tau inhibitor; neuronal stimulant | NCT02380573 | Recruiting | Texas Alzheimer's Research and Care Consortium | Jul-15 | Jul-18 |
| NewGam 10% IVIG | Anti-amyloid | Polyclonal antibody | NCT01300728 | Active, not recruiting | Sutter Health | Jan-11 | Nov-17 |
| Nicotine | Neurotransmitter based | Nicotinic acetylcholine receptor agonist | NCT02720445 | Not yet recruiting | University of Southern California, NIA, ATRI, Vanderbilt University | Dec-16 | Dec-19 |
| Nilotinib | Anti-tau | Tyrosine kinase inhibitor | NCT02947893 | Not yet recruiting | Georgetown University | Nov-16 | Mar-18 |
| ORM-12741 | Neurotransmitter based | Alpha-2c adrenergic receptor antagonist | NCT02471196 | Recruiting | Orion Corporation, Janssen | Jun-15 | Jul-17 |
| Pimavanserin | Neurotransmitter based | 5-HT2A inverse agonist | NCT02035553 | Active, not recruiting | Acadia | Nov-13 | Nov-16 |
| NCT02992132 | Recruiting | Acadia | Nov-16 | Jun-19 | |||
| Piromelatine | Neurotransmitter based | Melatonin receptor agonist; 5-HT 1A and 1D receptor agonist | NCT02615002 | Recruiting | Neurim Pharmaceuticals | Nov-15 | Mar-18 |
| Posiphen | Anti-amyloid | Selective inhibitor of APP production | NCT02925650∗ | Not yet recruiting | QR Pharma, ADCS | Dec-16 | Dec-18 |
| PQ912 | Anti-amyloid, anti-inflammatory | Glutaminyl-peptide cyclotransferase inhibitor | NCT02389413 | Recruiting | Probiodrug AG, Julius Clinical, VU University Medical Center, Amsterdam | Mar-15 | Mar-17 |
| Probucol | Neuroprotective, anti-inflammatory | Anti-hyperlipidemic | NCT02707458∗ | Not yet recruiting | Douglas Mental Health University Institute, Weston Brain Institute, McGill University | Apr-16 | May-18 |
| Rasagiline | Neuroprotective | Monoamine oxidase B inhibitor | NCT02359552 | Recruiting | The Cleveland Clinic | Feb-15 | May-17 |
| Riluzole | Neuroprotective | Glutamate receptor antagonist; glutamate release inhibitor | NCT01703117 | Recruiting | Rockefeller University | Apr-13 | Nov-18 |
| RVT-101 | Neurotransmitter based | 5-HT6 antagonist | NCT02910102 | Recruiting | Axovant Sciences | Oct-16 | Sep-17 |
| S47445 | Neurotransmitter based | AMPA receptor agonist; nerve growth factor stimulant | NCT02626572 | Active, not recruiting | Servier | Feb-15 | Dec-17 |
| Sargramostim (GM-CSF) | Anti-amyloid | Granulocyte colony stimulator; amyloid removal | NCT01409915 | Recruiting | University of Colorado, Denver, The Dana Foundation | Mar-11 | Jan-17 |
| NCT02667496 | Recruiting | Sanofi, NIA | Nov-16 | Apr-18 | |||
| Simvastatin + L-Arginine + Tetrahydrobiopterin (SLAT) | Neuroprotective | HMG-CoA reductase inhibitor and antioxidant | NCT01439555 | Recruiting | University of Massachusetts, Worcester | Nov-11 | Dec-16 |
| STA-1 | Neuroprotective, anti-inflammatory | Antioxidant properties of echinascoside | NCT01255046 | Not yet recruiting | Sinphar Pharmaceuticals | Dec-15 | Dec-18 |
| SUVN-502 | Neurotransmitter based | 5-HT6 antagonist | NCT02580305 | Recruiting | Suven Life Sciences | Sep-15 | Jun-17 |
| T-817 MA | Neuroprotective | Neurotrophic agent | NCT02079909 | Active, not recruiting | Toyama Chemical, ADCS | Mar-14 | Mar-17 |
| Telmisartan | Neuroprotective, anti-inflammatory | Angiotensin II receptor blocker, PPAR-gamma agonist | NCT02085265 | Recruiting | Sunnybrook Health Sciences Centre, ADDF | Mar-14 | Aug-18 |
| UB-311 | Anti-amyloid | Monoclonal antibody | NCT02551809 | Recruiting | United Neuroscience | Oct-15 | Dec-17 |
| Valacyclovir | Anti-amyloid, Anti-tau | Antiviral agent | NCT02997982 | Recruiting | Umea University | Dec-16 | Dec-17 |
| VX-745 | Neuroprotective, anti-inflammatory | P38 mitogen-activated protein kinase inhibitor | NCT02423200 | Active, not recruiting | EIP Pharma | Apr-15 | Nov-16 |
| NCT02423122 | Active, not recruiting | EIP Pharma | Apr-15 | Sep-16 | |||
| Xanamema | Neuroprotective | Blocks 11-HSD1 enzyme activity, decreasing cortisol in brain | NCT02727699 | Not yet recruiting | Actinogen Medical, ICON Clinical Research | Jun-16 | Aug-18 |
Abbreviations: ADCS, Alzheimer's Disease Cooperative Study; ADDF, Alzheimer's Drug Discovery Foundation; AD-SVF, adipose-derived stromal vascular fraction; AMPA, α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid; ATP, adenosine triphosphate; ATRI, Alzheimer's Therapeutic Research Institute; BACE, β-site amyloid precursor protein cleaving enzyme; GM-CSF, granulocyte-macrophage colony-stimulating factor; HMG-CoA, 3-hydroxy-3-methylglutaryl-coenzyme; hUCB-MSCs, human umbilical cord-derived mesenchymal stem cells; IVIG, intravenous immunoglobulin; NIA, National Institute on Aging; NMDA, N-methyl-d-aspartate; PPAR, peroxisome proliferator-activated receptor; SNRI, serotonin-norepinephrine reuptake inhibitors.
NOTE. Fifty-two agents in 68 phase II clinical trials currently ongoing as of January 5, 2017 according to clinicaltrials.gov.
∗
Phase I/II trials. Bolded = new entries into the 2017 phase II pipeline.