Enable access to data and associated biosamples and biomarkers from completed, ongoing, and future federally and privately funded clinical trials to clarify the biomarkers’ predictive and theragnostic value, to identify surrogate endpoints, and to advance the understanding of heterogeneity of disease and treatment response.
Provide supplemental funding to enhance completed and ongoing clinical trials with molecular profiling of minimally invasive specimens (serum, peripheral monocytes, microbiome etc.) and use these molecular signatures as indicators of responsiveness and for disease sub-classification.
Develop standard consenting language, simplified data, and material transfer agreements, and provide support for big data infrastructure to ensure the rapid, widespread and appropriate, use/reuse of data and biosamples.
Align funding incentives across federal and non-federal/private trial sponsors to ensure rapid and broad access to data and associated biosamples and biomarkers from legacy, ongoing and future clinical trials.
- Research Implementation Area
- Data Sharing and Reproducibility
- In Progress
- RFA-AG-17-005: Alzheimer's Clinical Trials Consortium (ACTC) (U24)
- PAR-18-513: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01)
- PAR-18-877: Early Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)
- PAR-18-878: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01)
- RFA-OD-19-018: Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33)
- PA-16-259: Inclusion of Mobile/e-Consents for Alzheimer’s Disease Research (Admin Supp)
Research Programs and Resources
- Accelerating Medicines Partnership – Alzheimer’s Disease (AMP-AD) Biomarkers Project
- Ongoing Alzheimer’s and Related Clinical Trials and Studies
- Alzheimer’s Clinical Trials Consortium (ACTC)
- Alzheimer’s Prevention Initiative (API)
- Anti-Amyloid Treatment In Asymptomatic Alzheimer’s Disease Study (A4 study)
- Dominantly Inherited Alzheimer's Network Trials Unit - Adaptive Prevention Trial (DIAN-TU)
- National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD): Accessing Biospecimens and Data
- The INCLUDE Project
- Clinical Trials to Prevent Alzheimer’s Disease in Down Syndrome
- Clinical Trials Development for Co-Occurring Condition in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33) •