Drug Development/Novel Targets: Phase 1 trials

Initiate first in human, Phase 1 drug trials for therapeutic agents against at least 6 novel therapeutic targets. These trials will provide evidence of safety and target engagement.

2030 PAR-12-015: Alzheimer's Drug-Development Program (U01) PAR-15-174: Alzheimer's Drug-Development Program (U01) PAR-18-820: Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) RFA-AG-13-016: Alzheimer's Disease Phase I Clinical Trials (R01) 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) 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) 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) PAR-23-274: Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required) PAR-24-063: Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) PAR-24-293: Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional) PAR-24-294: Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) PAR-25-051: Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional) PAR-25-297: Alzheimer's Drug-Development Program (U01 Clinical Trial Optional) 6.E In Progress Initiate first in human, Phase 1 drug trials for therapeutic agents against at least 6 novel therapeutic targets... DN 2012 AD Summit: 3A, 3B, 3F, and 5E Drug Development - Novel Targets NIA Ongoing Alzheimer’s and Related Clinical Trials and Studies First-in-human SAD & MAD trials for MW151, a novel Alzheimer's disease drug candidate that attenuates proinflammatory cytokine dysregulation Allopregnanolone Regenerative Therapeutic for MCI/AD: Dose Finding Neuron Regenerative Therapeutic, NNI-362, for First-in-Human Safety and PK for AD BPN14770 Safety and Cognitive Effect in Young And Elderly Subjects NIA-AA Symposium: Enabling Precision Medicine for Alzheimer's Disease Through Open Science A Clinical Trial of AAV2-BDNF Gene Therapy in Alzheimer's Disease First-in-Human (Phase 1) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBC-Ab002 in Persons with Early Alzheimer's Disease (AD) Phase 1 Clinical Trial of CMS121, a Novel Therapeutic Candidate for Alzheimer's Disease Phase I clinical trial NCT06546449: LH-001 Vs Placebo in Healthy Participants 2017

• Completion of 12 Phase 1 drug trials for agents against 6 novel targets, providing conclusive evidence of safety and target engagement.