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. 2019;6(3):157-163.
doi: 10.14283/jpad.2019.14.

Anti-Tau Trials for Alzheimer's Disease: A Report from the EU/US/CTAD Task Force

J Cummings  1 , K Blennow, K Johnson, M Keeley, R J Bateman, J L Molinuevo, J Touchon, P Aisen, B Vellas
Affiliations

Anti-Tau Trials for Alzheimer's Disease: A Report from the EU/US/CTAD Task Force

J Cummings et al. J Prev Alzheimers Dis. 2019.

Abstract

Efforts to develop effective disease-modifying treatments for Alzheimer's disease (AD) have mostly targeted the amyloid β (Aβ) protein; however, there has recently been increased interest in other targets including phosphorylated tau and other forms of tau. Aggregated tau appears to spread in a characteristic pattern throughout the brain and is thought to drive neurodegeneration. Both neuropathological and imaging studies indicate that tau first appears in the entorhinal cortex and then spreads to the neocortex. Anti-tau therapies currently in Phase 1 or 2 trials include passive and active immunotherapies designed to prevent aggregation, seeding, and spreading, as well as small molecules that modulate tau metabolism and function. EU/US/CTAD Task Force members support advancing the development of anti-tau therapies, which will require novel imaging agents and biomarkers, a deeper understanding of tau biology and the dynamic interaction of tau and Aβ protein, and development of multiple targets and candidate agents addressing the tauopathy of AD. Incorporating tau biomarkers in AD clinical trials will provide additional knowledge about the potential to treat AD by targeting tau.

Keywords: Alzheimer’s disease; biomarkers; tau; tauopathy; therapeutics.

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Conflict of interest statement

The Task Force was partially funded by registration fees from industrial participants. These corporations placed no restrictions on this work. Dr. Cummings is the Chief Scientific Officer of CNS Innovations. He acknowledges funding from the National Institute of General Medical Sciences (Grant: P20GM109025) and support from Keep Memory Alive; Consultation for Pharmaceutical Companies: Dr. Cummings has provided consultation to Acadia, Accera, Actinogen, AgeneBio, Alkahest, Allergan, Alzheon, Avanir, Axsome, Binomics, BiOasis Technologies, Biogen, Bracket, Denali, Diadem, EIP Pharma, Eisai, Genentech, Green Valley, Grifols, Hisun, Idorsia, Lundbeck, MedAvante, Merck, Otsuka, Pain Therapeutics, Probiodrug, Proclara, QR, Resverlogix, Roche, Samumed, Shinkei Therapeutics, Sunovion, Suven, Takeda, and United Neuroscience pharmaceutical and assessment companies. Consultation for Foundations: Dr. Cummings has provided consultation to Global Alzheimer Platform (GAP). Stock: Dr. Cummings owns stock in ADAMAS, BioAsis, Prana, MedAvante, Neurokos, and QR Pharma. Board member: None. Speaker/lecturer: None. Other: Dr. Cummings owns the copyright of the Neuropsychiatric Inventory (NPI). Dr. Cummings is the Chief Scientific Officer of CNS Innovations.Expert witness/legal consultation: None. NIH support: COBRE grant # P20GM109025; TRC-PAD # R01AG053798; DIAGNOSE CTE # U01NS093334.Research Support: None. Spousal ownership or significant financial interest in a relevant company: CNS Innovations. Dr. Johnson has consulted for Merck, Eli Lilly, Novartis, Biogen, Takeda, Roche, Eisai, Piramal, and GE. Dr. Keeley reports that he is an employee of Genentech. Dr. Bateman reports grants from BrightFocus Foundation, Pharma Consortium (Abbvie, AstraZeneca, Biogen, Eisai, Eli Lilly and Co., Hoffman La-Roche Inc., Janssen, Pfizer, Sanofi-Aventi), the Tau SILK/PET Consortium (Biogen/Abbvie/Lilly), Association for Frontotemporal Degeneration FTD Biomarkers Initiative, Anonymous Foundation, GHR Foundation, NIH, Alzheimer’s Association, Lilly, Rainwater Foundation Tau Consortium, and Cure Alzheimer’s Fund, grants, personal fees and non-financial support from Roche and Janssen, personal fees and non-financial support from Pfizer, Eisai, and Merck, and non-financial support from Avid Radiopharmaceuticals outside the submitted work. Washington University, Dr. Bateman, and David Holtzman have equity ownership interest in C2N Diagnostics and receive royalty income based on technology (stable isotope labeling kinetics and blood plasma assay) licensed by Washington University to C2N Diagnostics. RJB receives income from C2N Diagnostics for serving on the scientific advisory board. Washington University, with RJB as co-inventor, has submitted the US nonprovisional patent application “Methods for Measuring the Metabolism of CNS Derived Biomolecules In Vivo” and provisional patent application “Plasma Based Methods for Detecting CNS Amyloid Deposition”. Dr. Molinuevo reports personal fees from Alergan, from Oryzon, from Genentech, from Novartis, from Lundbeck, from Biogen, from Lilly, from Janssen, Green Valley, from MSD, from Eisai, from Alector and from Raman Health, outside the submitted work. Dr. Touchon has nothing to disclose. Dr. Aisen reports grants from Lilly, personal fees from Proclara, other from Lilly, other from Janssen, other from Eisai, grants from Janssen, grants from NIA, grants from FNIH, grants from Alzheimer’s Association, personal fees from Merck, personal fees from Roche, personal fees from Lundbeck, personal fees from Biogen, personal fees from ImmunoBrain Checkpoint, outside the submitted work. Dr. Vellas reports grants from Lilly, Merck, Roche, Lundbeck, Biogen, grants from Alzheimer’s Association, European Commission, personal fees from Lilly, Merck, Roche, Biogen, outside the submitted work

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