National Plan to Address Alzheimer's Disease: 2018 Update. Strategy 1.C: Accelerate Efforts to Identify Early and Presymptomatic Stages of Alzheimer's Disease and Related Dementias


Significant advances in the use of imaging and biomarkers in brain, blood, and spinal fluid have made it possible to detect the onset of AD/ADRD and track its progression, with the hope that it will be possible to monitor the effect of treatment in people with the disease. Without these advances, these neurodegenerative processes could only be evaluated in non-living tissues. Accelerated research will improve and expand the application of biomarkers in research and practice. These advances have shown that the brain changes that lead to AD/ADRD begin up to 10 years before symptoms. Identifying imaging and other biomarkers in presymptomatic people will facilitate earlier diagnoses in clinical settings, as well as aid in the development of more efficient interventions to slow or delay progression.

(UPDATED) Action 1.C.1: Identify imaging and biomarkers to monitor disease progression

The Alzheimer's Disease Neuroimaging Initiative (ADNI) has contributed to much progress in neuroimaging and biomarker refinement. ADNI, a long-running, NIH-supported study, was designed to develop tools for clinical trials by tracking how neuroimaging and fluid biomarkers change with disease onset and progression. Launched by NIH in 2004, this landmark public-private partnership looks at how the evolution of clinical symptoms and neurocognitive testing in healthy controls, people with mild cognitive impairment (MCI), and people with mild AD correlates with changes in multiple biomarkers reflecting disease development. The biomarkers developed and validated in ADNI are being used more and more in clinical trials. ADNI has also pioneered rapid, transparent data-sharing while protecting participants' privacy. Qualified researchers across the world can access ADNI brain scan images and biomarker data through a web-based portal as soon as data are quality-controlled and added to the database. ADNI also shares the blood, cerebrospinal fluid, and DNA it has collected with other investigators who are developing novel biomarkers.

Additionally, the Accelerating Medicines Partnership-Alzheimer's Disease (AMP-AD) Biomarkers Project, a public-private partnership, is exploring the utility of tau PET imaging and novel fluid biomarkers for tracking response to treatment and/or disease progression. Under the Biomarkers Project, NIA-supported, Phase II/III secondary prevention trials are testing several anti-amyloid therapies. Through the AMP-AD partnership, imaging and fluid biomarker tests already included in these trials will be supplemented with tau PET imaging and novel fluid biomarkers. Screening and baseline data from the trials will be made broadly available through the Global Alzheimer's Association Interactive Network collaborative platform. Trial data and biological samples will also be shared after the trials are completed.

To enable better patient stratification, diagnosis, and tracking of disease progression in LBD, FTC, VCID, and dementias with mixed etiologies, NINDS has released funding opportunities to support the development of biomarkers, including imaging ligands, for ADRD. NIH continues to support a small vessel VCID Biomarkers Consortium (MarkVCID) to develop and validate candidate human biomarkers for small vessel disease in the brain that would enable more accurate identification of those at risk for long-term cognitive decline and tracking of disease progression in individuals already affected by cognitive impairment and dementia. To improve differential diagnosis of LBD, two NIH-funded research teams are leveraging existing data and biospecimens from patients with LBD that are housed in databases of large NIH-supported programs, the ADNI/National Alzheimer's Coordinating Center (NACC) and the Parkinson's Disease Biomarker Program. NIH is also continuing to support five research teams that aim to discover biomarkers that will improve the efficiency and outcome of Phase II clinical trials for LBD.

In addition to these large initiatives, NIA and NINDS have released several FOAs in the past year that call for research to further the development of imaging and biomarker research.

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(UPDATED) Action 1.C.2: Maximize collaboration among federal agencies and with the private sector

NIH engages in multiple partnership opportunities with the private sector and other federal agencies to facilitate collaborative efforts across the entire AD/ADRD research landscape. ADNI and AMP-AD, discussed above, are two large examples of these partnerships.

Another example is the Collaboration for Alzheimer's Prevention (CAP). CAP is a public-private partnership that brings together research groups to harmonize biomarker, clinical, and cognitive measures and align data-sharing and sample-sharing approaches used in certain trials so that findings can inform the entire research community. CAP includes researchers from three trials co-funded by NIH, industry, and foundations: the Alzheimer's Prevention Initiative, the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease study, and the Dominantly Inherited Alzheimer Network Trials Unit. Collaborative efforts like CAP provide an effective platform for implementation of AD research standards and advancing AD prevention research with rigor, care, and maximal impact.

Tau Center Without Walls (CWOW) is a multi-center, interdisciplinary program that was established in FY 2016 to investigate the molecular mechanisms of tau toxicity in FTD. One of the requirements of this program is to have ongoing collaborative partnerships with non-profit non-governmental organizations and philanthropic entities, such as the Association for Frontotemporal Degeneration (AFTD), Cure PSP, and the Rainwater Charitable Foundation.

Also, the International Alzheimer's and Related Dementias Research Portfolio (IADRP) facilitates the tracking of research support in the public and private sectors, including the initiatives mentioned above.

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