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AD-Related Dementias Focus
Prepare for and initiate clinical trials that aim to alleviate or slow the course of LBD symptoms, and delay or prevent the onset of disease.
2033 RFA-NS-18-017: Planning Grant to Develop Phase III Clinical Trials for Lewy Body Dementia (R34) PAR-19-170: Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01) RFA-NS-19-015: Functional Target Validation for Alzheimer's Disease-Related Dementias (ADRDs) (UG3/UH3) PAS-19-210: Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01) RFA-NS-21-008: Treatments for Lewy Body Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required) NOT-NS-21-040: Administrative Supplements for Collaborative Activities to Promote Sleep/Circadian Research in ADRD RFA-NS-22-056: Treatments for Lewy Body Dementias and Frontotemporal Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required) RFA-NS-25-010: Safety and Efficacy of Amyloid-Beta Directed Antibody Therapy in Mild Cognitive Impairment and Dementia with Evidence of Lewy Body Dementia and Amyloid-Beta Pathology (U01 - Clinical Trial Required) 5.D In Progress DN 2019 ADRD Summit Recommendations 2022 ADRD Summit: Lewy Body Dementias (LBD) Milestone 1, Priority 1 Drug Development - Existing Targets Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01) Functional Target Validation for Alzheimer's Disease-Related Dementias (ADRDs) (UG3/UH3) A randomized, double blind, placebo-controlled study to evaluate the impact of Nilotinib treatment on safety, tolerability, pharmacokinetics and biomarkers in Dementia with Lewy Bodies (DLB) Select projects funded in FY21 Neurostimulation of the Nucleus Basalis of Meynert for the cognitive-motor syndrome in Parkinson's disease Fluorescent IRE sensor for synucleinopathy drug discovery 2016
- An LBD clinical trial network with the personnel and infrastructure to conduct clinical trials, including validated clinical tools to track LBD symptoms.
- Complete one or more clinical trials that test prospective therapies to prevent or alter LBD processes or symptoms.
Summary of Key Accomplishments
NIH has funded several early phase clinical trials for LBD, most of which are ongoing. One Phase 2 trial is testing the effect of a sigma-2 receptor antagonist, CT1812, believed to remove toxic beta-amyloid and alpha-synuclein from the brain, to determine if it will improve cognition in people living with dementia with Lewy bodies (DLB). Another Phase 2b trial is investigating whether the drug neflamapimod can improve cognition and mobility in people with DLB. A trial of the drug nilotinib to clear abnormal alpha-synuclein deposits in people with DLB and improve cognition recently completed data collection, and results are currently pending. In addition, a proof-of-concept trial is looking at whether the drug citalopram can slow the buildup of beta-amyloid in the brain and cognitive decline in patients with Parkinson's disease dementia (PDD). Further, an NIH-funded small business will assess the ability of a brain stimulation device to improve cognition, memory, and mood in patients with PDD.
The key accomplishments summary is current as of June 2024.