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Initiate early clinical development for at least 6 approved drugs or drug combinations for the treatment or prevention of AD and AD-related dementias.
2030 PAR-14-089: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) PAR-16-365: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) PAR-18-175: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) PAR-18-877: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) PAS-17-064: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44) PAS-18-187: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional) PAS-17-065: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42) PAS-18-188: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42 Clinical Trial Optional) PAR-18-877: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Optional) PAR-21-359: Early and Late Stage Clinical Trials for the Spectrum of Alzheimer’s Disease/Alzheimer’s Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional) 7.D In Progress Initiate early clinical development for at least 6 existing drugs or drug combinations for the treatment or prevention of AD and AD-related dementias. DN 2012 AD Summit: 4A, 4B, 4C, and 4D News: Could taking statins prevent dementia, disability? Drug Repurposing and Combination Therapy Development NIA Ongoing Alzheimer’s and Related Clinical Trials and Studies Escitalopram for Agitation in Alzheimer's Disease Anti-Viral therapy in Alzheimer's disease Lithium for Treatment of psychosis and agitation in Alzheimer's disease Long-term Nicotine Treatment of Mild Cognitive Impairment A Biomarker-Driven Trial of Angiotensin Receptor Blockers for Prodromal Alzheimer’s Antiviral Valacyclovir for therapy in AD Dronabinol for agitation in AD Lenalidomide to treat AD Evaluation of Brain and Cognitive Changes in Older Adults with MCI Taking Lithium to Prevent Alzheimer Type Dementia LUCINDA trial ( Lupron + AChEi) for AD Apathy in Alzheimer's Disease Methyphenidate Trial II (ADMET II) Repurposing Siponimod for Alzheimer's Disease RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep with Trazodone (Rest) Effects of NAD restoration on neurovascular coupling in community dwelling older adults PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial Arterial Stiffness, Cognition, and Equol (ACE) Phase II randomized controlled trial of benfotiamine in early Alzheimer's Disease 2018
- Completion of at least 4 phase II trials with repurposed drugs and/or drug combinations. Successful trials will provide conclusive evidence of therapeutic mechanism/target engagement.
Summary of Key Accomplishments
Fourteen early-stage clinical trials (Phase 1 and 2) testing 11 different FDA-approved drugs repurposed for the treatment of AD/ADRD have been supported. The pilot trials for candesartan (an antihypertensive), nicotine (used for smoking cessation) and metformin (a drug used to treat diabetes) showed positive results, and these repurposed drug candidates have been advanced to larger Phase 2 trials (candesartan and nicotine) and Phase 2/3 trials (metformin). In addition, six early-stage clinical trials have been supported to test six different dietary supplements as potential AD treatments. One of these trials testing the supplement benfotiamine, a synthetic derivative of vitamin B1, showed positive results and can be advanced to Phase 3 testing.
The key accomplishments summary is current as of July 2022.