Biomarkers: Incorporate biomarkers into Phase 2 trials (Milestone 9.D)
Timeline Start - End2017 - 2023
Research Implementation AreaBiomarkers
Incorporate imaging and/or fluid biomarkers into Phase 2 (proof of concept) drug trials to provide proof of mechanism and/or evidence of target engagement as trials for 3-6 existing and 3-6 novel therapeutic targets are initiated.
Enrich 3-6 Phase 2 (proof of concept) drug trials with imaging and/or fluid biomarkers for proof of target engagement and proof of clinical mechanisms.
Summary of Key Accomplishments
Eleven AD Phase 2 trials have been enriched with imaging and/or fluid biomarkers. These trials are testing three new drug candidates, six repurposed drugs, and two nutritional supplements. The embedding of imaging/fluid biomarkers trials will enable the investigators to evaluate whether the targeted disease process was affected by the treatment and led to beneficial change in AD/ADRD biomarkers. In addition, per NIA’s requirements, the data and biosamples from these trials will be made available to qualified investigators from the wider research community. This is key for enabling a comprehensive success/failure analysis and evaluating responsiveness to the treatment.
The key accomplishments summary is current as of March 2022.
- 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)
- PAR-18-877: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)
- PAS-18-187: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R43/R44)
- PAS-18-188: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42)
Research Programs and Resources
- A Pilot Synaptic Vesicle Glycoprotein 2A (SV2A) PET Study to Evaluate the Effect of CT1812 Treatment on Synaptic Density in Subjects with Mild to Moderate Alzheimer's Disease
- A double-blinded, randomized, controlled phase 2a safety, proof-of-concept and exploratory end point trial of the drug LM11A-31 in patients with mild to moderate Alzheimer's disease.
- Evaluation of Brain and Cognitive Changes in Older Adults with MCI Taking Lithium to Prevent Alzheimer Type Dementia
- Allopregnanolone as Regenerative Therapeutic for Alzheimer’s: Phase 2 Clinical Trial
- Antiviral Valacyclovir for therapy in AD
- Lenalidomide to treat AD
- LUCINDA trial (Lupron + AChEi) for AD
- Therapeutic Effect of Intranasal Insulin on Cognition, Function, and AD Biomarkers (SNIFF Study)
- Development of a stress kinase inhibitor therapeutic candidate for Alzheimer's Disease and related dementia
- Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
- Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia
- Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease over 18 Months