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Initiate Phase 2 (proof of concept) drug trials for agents against 3-6 currently known therapeutic targets. Of these at least 2 will be for targets involved in at-risk asymptomatic individuals (e.g. FAD or ApoE4 carriers, Down syndrome, amyloid positive, type II diabetes, etc.) These trials will be designed to provide or confirm proof of mechanism and/or evidence of target engagement for the therapeutic agent being tested.
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) 5.B In Progress Initiate Phase 2 (proof of concept) drug trials for agents against 3-6 currently known therapeutic targets… DN 2012 AD Summit: 3A, 3B, 3F, and 5E News: INCLUDE Project: "New NIH grant awards boost funding for research on Down syndrome" Drug Development - Existing Targets NIA Ongoing Alzheimer’s and Related Clinical Trials and Studies AD/ADRD Clinical Trials Infrastructure: Alzheimer's Clinical Trials Consortium Clinical Trials to Prevent Alzheimer’s Disease in Down Syndrome Alzheimer’s Prevention Initiative (API) ADAD Columbia Trial 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 Lenalidomide to treat AD CT1812, Small Molecule Targeting a Synaptic Receptor for Abeta Oligomers LUCINDA trial ( Lupron + AChEi) for AD DIAN-TU: Tau Next Generation Prevention Trial A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Dementia with Lewy Bodies 2015
- Completion of 3-6 Phase 2 drug trials for agents against currently known targets, providing conclusive evidence of therapeutic mechanism/target engagement.
Summary of Key Accomplishments
Ten Phase 2 trials testing eight new drug candidates for existing targets (amyloid/tau/acetylcholinesterase) have been supported. Of these, seven trials are in asymptomatic, at-risk individuals and three trials are in individuals symptomatic for late-onset AD. Of the ten Phase 2 trials:
- one trial testing two drugs (DIAN-TU) was successfully completed and advanced into Phase 3 testing
- seven trials are ongoing
- one trial (API-ApoE4) was terminated early due to lack of efficacy and unanticipated toxicity
- one trial is expected to be initiated in 2022
The key accomplishments summary is current as of July 2022.