LBD: Biomarker development (Milestone 9.P)
Timeline Start - End2016 - 2027
Research Implementation AreaBiomarkers
AD-Related Dementias Focus
Develop and refine biomarkers for diagnosis, prediction, and prognosis utilizing biofluids, tissues, and digital and electrophysiological methods.
- At least one clinical trial ready validated LBD biomarker that uses biofluids, tissues, digital or electrophysiological approaches (or a combination of approaches) for LBD diagnosis, prediction, and/or prognosis.
Summary of Key Accomplishments
Several recently-funded awards are currently evaluating the utility of various biomarkers for LBD, including studies that are testing skin biopsies for abnormal alpha-synuclein in individuals with LBD, which appears to be a very promising biomarker assay that is extremely sensitive and specific for alpha-synuclein-related disorders. In one study, researchers demonstrated that this assay can successfully differentiate individuals with dementia with Lewy bodies (DLB) from individuals with Parkinson's disease (PD) even though both disorders develop abnormal alpha-synuclein deposits in the brain. Another research team showed that higher blood levels of a particular protein known as neurofilament light chain predicted which individuals with PD would go on to develop PD with dementia (PDD). Both alpha-synuclein and neurofilament light chain biomarker assays are being performed in the large, longitudinal NAPS2 study to determine if they are associated with progression from REM sleep behavior disorder to LBD.
The key accomplishments summary is current as of July 2022.
- RFA-NS-16-022: Biomarkers for the Lewy Body Dementias (U01)
- RFA-NS-17-016: Leveraging Existing Resources for Research on Lewy Body Dementia (R03
- PAR-19-170: Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01)
- RFA-NS-19-014: Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19)
- RFA-NS-20-014: Peripheral Pathology in the Lewy Body Dementias
- NOT-NS-21-001: Notice of Special Interest: Administrative Supplements for Connecting Pre-mortem Clinical Information with Post-Mortem Brain Analysis
- RFA-NS-22-001: Biomarkers for the Lewy Body Dementias (U01 Clinical Trial Not Allowed)
- RFA-NS-22-062: Connecting Machine Readable Digital Human AD/ADRD Neuropathological Library Platforms for Advanced Analytics (U24 Clinical Trial Not Allowed)
Research Programs and Resources
- Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01)
- Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19)
- NINDS Parkinson’s Disease Biomarkers Program (PDBP)
- NIH NeuroBioBank
- NINDS BioSEND
- NINDS Human Cell and Data Repository (NHCDR)
- Select projects funded in FY21
- Select projects funded in FY22
- 2016 ADRD Summit: Lewy Body Dementias (LBD) Focus Area 3: Develop and Validate Biological and Imaging Biomarkers, Recommendation 6
- 2022 ADRD Summit: Lewy Body Dementias (LBD) Milestone 3, Priority 3