Abstract
While amyloid-targeting therapies continue to predominate in the Alzheimer’s disease (AD) drug development pipeline, there is increasing recognition that to effectively treat the disease it may be necessary to target other mechanisms and pathways as well. In December 2019, The EU/US CTAD Task Force discussed these alternative approaches to disease modification in AD, focusing on tau-targeting therapies, neurotrophin receptor modulation, anti-microbial strategies, and the innate immune response; as well as vascular approaches, aging, and non-pharmacological approaches such as lifestyle intervention strategies, photobiomodulation and neurostimulation. The Task Force proposed a general strategy to accelerate the development of alternative treatment approaches, which would include increased partnerships and collaborations, improved trial designs, and further exploration of combination therapy strategies.
Highlights
Following a discussion on lessons learned from clinical trials of amyloid-based therapies for Alzheimer’s disease (AD) [1], on December 4, 2019, the EU/US CTAD Task Force turned their attention to alternative approaches for disease modification
These strategies do not negate the validity of the amyloid hypothesis; recently discovered genetic evidence continues to support the centrality of amyloid in the neurodegenerative processes that lead to AD [2,3,4]
A Phase 2 study underway in participants with late mild cognitive impairment (MCI) or early AD aims to protect neurons against oxidative stress using two small molecule drugs -- tauroursodexycholic acid (TUDCA) and sodium phenylbutyrate -- repurposed by Amylyx Pharmaceutical as AMX0035 (NCT03533257)
Summary
Non-Amyloid Approaches to Disease Modification for Alzheimer’s Disease: An EU/US CTAD Task Force Report. Alzheimer’s Therapeutic Research Institute (ATRI), Keck School of Medicine, University of Southern California, San Diego, CA, USA; 3. Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA; 5. Stanford University School of Medicine, Stanford CA USA; 7. University of Southern California Keck School of Medicine, Los Angeles, CA USA; 8. Banner Alzheimer’s Institute, Phoenix AZ USA; 10. University of California, San Francisco, CA USA; 11. Montpellier University, INSERM 1061, Montpellier, France; 12. Gerontopole, INSERM U1027, Alzheimer’s Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France.
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