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[Alzheimer's disease-Which substances are at present in phase III studies?]

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BACKGROUND The recent approval of aduhelm/aducanumab by the US Food and Drug Administration (FDA) in June 2021 raised hopes that further substances against Alzheimer's disease might be approved in the… Click to show full abstract

BACKGROUND The recent approval of aduhelm/aducanumab by the US Food and Drug Administration (FDA) in June 2021 raised hopes that further substances against Alzheimer's disease might be approved in the near future. OBJECTIVE The current status of phase III studies for Alzheimer's disease was evaluated. MATERIAL AND METHODS The American database www. CLINICALTRIALS gov was searched on 7 August 2021 for phase III studies which target the cognitive functions affected by Alzheimer's disease. The mode of action of the different substances was classified according to the Common Alzheimer's Disease Research Ontology (CADRO). RESULTS With the applied search criteria 53 studies were found, 32 studies with 25 substances dealt with cognition, which was demonstrated by a cognition test as one of the primary outcome measures, 20 of the studies are recruiting, 4 are not yet recruiting and 8 studies are active but not recruiting. Of the studies seven target amyloid beta-peptide as well as tau protein. For 20 substances a disease modifying action is assumed. In 2022 and 2023 a total of 8 studies each are planned to be terminated. CONCLUSION The mode of action of the substances, which are currently in studies, seems broad and for their action a modification of the disease is mostly assumed. Therefore, there is hope that in the next 2 years further drugs against Alzheimer's disease might be approved.

Keywords: iii studies; phase iii; alzheimer disease; disease

Journal Title: Der Nervenarzt
Year Published: 2022

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