Drug Development/Novel Targets: Phase 1 trials (Milestone 6.E)
In Progress
Timeline Start - End
2017 - 2024Research Implementation Area
Drug Development - Novel TargetsInitiate 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.
Success Criteria
- Completion of 12 Phase 1 drug trials for agents against 6 novel targets, providing conclusive evidence of safety and target engagement.
Summary of Key Accomplishments
Eight Phase 1 trials testing seven new drug candidates that target multiple aspects of the disease (neuroinflammation, metabolism, synaptic plasticity, neurogenesis, etc.) have been supported. Of these, three trials have been successfully completed. Results are pending from one additional trial, and three trials are ongoing.
The key accomplishments summary is current as of July 2022.
Accomplishments/Implementation Activities
Funding Initiatives
- 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)
Research Programs and Resources
- 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