NATIONAL PLAN TO ADDRESS ALZHEIMER'S DISEASE: 2017 UPDATE. Strategy 1.C: Accelerate Efforts to Identify Early and Presymptomatic Stages of Alzheimer's Disease and Related Dementias

09/01/2017

Strengthening Clinical Trials with Neuroimaging. The Alzheimer's Disease Neuroimaging Initiative (ADNI), initially launched by NIH in 2004 as a landmark public-private partnership, looks at how evolution of clinical symptoms and neurocognitive testing in healthy controls, people with MCI, and people with mild AD, correlates with changes in multiple biomarkers reflecting disease development. In 2016, ADNI moved into a critical new phase of discovery with ADNI3. With $40 million in NIH funding support over the next 5 years, plus an anticipated $20 million in private sector investment, the new effort will add brain scans that detect the amount and location of tau protein tangles -- a second hallmark of AD -- with ongoing collection of initial study neuroimaging and biofluid biomarkers.

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Collaborating on Biomarker Research. One of the primary goals of the previously-noted AMP is to identify and characterize biomarkers and targets for intervention. The AMP-AD Biomarkers Project is a consortium of three NIA-supported Phase II/III secondary prevention trials testing several anti-amyloid therapies. Imaging and fluid biomarker panels 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 completion of the trials.

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Identifying Biomarker Trajectories Over Time. In late 2015, NIH launched a new initiative to identify biomarkers and track the progression of AD in people with Down syndrome. Costing an estimated $37 million over 5 years, the NIH Alzheimer's Biomarker Consortium-Down Syndrome is supporting teams of researchers using brain imaging, including amyloid and tau PET, fluid and tissue biomarkers, as well as neuropsychological measures in research that may one day lead to effective interventions for all people with dementia. Two research teams are working collaboratively to identify and track AD-related changes in the brain and cognition of over 500 Down syndrome volunteers, aged 25 and older.

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Discovering Biomarkers for Alzheimer's Disease and Related Dementias. In addition to its ongoing support of several large collaborative projects and consortia that seek to discover biomarkers for FTD, NIH is supporting three programs that aim to discover and/or develop biomarkers for small vessel disease in the brain and LBD:

  • In 2016, NIH established a small vessel VCID Biomarkers Consortium (MarkVCID), which consists of seven biomarker development project sites and one coordinating center across the United States, to develop and validate candidate human biomarkers for small vessel disease in the brain. The 5-year program's overall goal is to deliver high-quality biomarkers ready for use in clinical trials.
  • NIH is supporting longitudinal studies that leverage the existing Parkinson's disease Biomarkers Program (PDBP) infrastructure to discover biomarkers for LBD. These studies began enrollment in March 2017 and will enroll 590 participants with clinical follow-up and biospecimen collection.
  • In 2017, NIH solicited LBD projects that could lead to early diagnosis, improved differential diagnosis, and/or discovery of new therapeutic targets. Funded projects would utilize existing data and biospecimens from the PDBP and ADNI/National Alzheimer's Coordinating Center databases to study unique clinical or biological characteristics of LBD patients.

     

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Early Detection of Cognitive Impairment, including Dementias, in Everyday Clinical Settings. Diagnostic tools for AD/ADRD that are accurate and reliable are crucial not only in guiding clinical care and developing a long-term care plan, but also in facilitating clinical research and recruiting the right subset of participants to clinical trials. To address the unmet need for early detection of cognitive impairment and dementia when a patient, relative, or care provider voices a concern in primary care settings, NIH released a new funding opportunity in early 2017 to develop easy-to-use diagnostic tests or tools that are standardized and take 5 minutes or less to administer in everyday clinical settings.

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Frontotemporal Degeneration Biomarkers Initiative. In January 2017, AFTD proudly announced the recipients of the first six awards funded through its major new funding opportunity, the FTD Biomarkers Initiative. Through 2018, AFTD anticipates awarding up to $5 million to support innovative approaches to the discovery and development of biomarkers that differentiate FTD from other neurodegenerative disorders, discriminate between FTD subtypes, identify underlying molecular pathologies, confirm pharmacodynamic modulation of disease pathways and track disease progression. A key feature of the initiative is the requirement for award recipients to commit to the open exchange of data and results. The FTD Biomarkers Initiative has been made possible by a generous multi-year donation from the Samuel I. Newhouse Foundation.

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Comprehensive Lewy Body Dementia Symptoms Checklist. LBDA's free, downloadable Comprehensive LBD Symptoms Checklist was used in a recent study by researchers at Newcastle University in the United Kingdom to tease out what symptoms of dementia with Lewy bodies (DLB) may aid in the early diagnosis during the MCI stage. Ten early symptoms were identified, with a score of 2 or more strongly suggesting MCI-DLB.

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