{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Sabbagh MN"],"funding":["NIA NIH HHS","Lewy Body Dementia Association","NINDS NIH HHS","National Institutes of Health"],"pagination":["e12375"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9983146"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["9(1)"],"pubmed_abstract":["The regulatory path for drug approval is increasingly well defined. Drugs for the treatment of Alzheimer disease (AD) need to show statistically significant benefit over placebo with respect to cognitive and functional measures, with the Clinical Dementia Rating scale and Alzheimer's Disease Assessment Scale-Cognitive Subscale being among the most often used instruments in AD clinical trials. In contrast, there are no validated instruments for use in clinical trials of drugs for the treatment of dementia with Lewy bodies. This poses challenges for drug development because the regulatory pathway to drug approval requires demonstrable efficacy measures. In December 2021, the Lewy Body Dementia Association advisory group met with representatives from the US Food and Drug Administration to dis"],"journal":["Alzheimer's & dementia (New York, N. Y.)"],"pubmed_title":["Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel."],"pmcid":["PMC9983146"],"funding_grant_id":["U01 NS100610","R01 AG057552","P30 AG072980","U19‐AG062418","R01 AG071643","RF1 AG071566","P20 AG068053","U01 AG073323","R01 NS101483","R01 AG071514","P01 AG066584","NIH R01AG059008","R01 NS101483‐S1","NIH R01AG073212","R01 AG069765","P30 AG072959","R01AG022304","P30 AG059295","R01 AG073212","R01 AG057681","NIH P30 AG072980","R56 AG074001","R01 AG059008","U19 AG062418","R01 AG022304","R01 AG070736"],"pubmed_authors":["Poston KL","Galvin JE","Goldman JG","Quinn JF","Irwin DJ","Galasko D","Leverenz JB","Sabbagh MN","Boeve BF","Taylor A"],"additional_accession":[]},"is_claimable":false,"name":"Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel.","description":"The regulatory path for drug approval is increasingly well defined. Drugs for the treatment of Alzheimer disease (AD) need to show statistically significant benefit over placebo with respect to cognitive and functional measures, with the Clinical Dementia Rating scale and Alzheimer's Disease Assessment Scale-Cognitive Subscale being among the most often used instruments in AD clinical trials. In contrast, there are no validated instruments for use in clinical trials of drugs for the treatment of dementia with Lewy bodies. This poses challenges for drug development because the regulatory pathway to drug approval requires demonstrable efficacy measures. In December 2021, the Lewy Body Dementia Association advisory group met with representatives from the US Food and Drug Administration to dis","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jan-Mar","modification":"2025-04-04T20:17:40.558Z","creation":"2025-02-18T23:35:24.076Z"},"accession":"S-EPMC9983146","cross_references":{"pubmed":["36873923"],"doi":["10.1002/trc2.12375"]}}