論争の的となったアルツハイマー病治療薬の承認が、驚くべき衝撃をもたらす(Controversial Alzheimer’s drug approval sparks surprising impact)

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2022-11-29 カリフォルニア大学校アーバイン校(UCI)

 米国食品医薬品局(FDA)が、約20年ぶりにアルツハイマー病治療薬の早期承認を行って物議を醸したとき、この病気の研究に対する態度に驚くべき影響を及ぼしたことが分かった。カリフォルニア大学アーバイン校の神経科学者が行った調査によると、FDAの決定に関する報道によって、一般の人々はアルツハイマー病の医薬品の臨床試験にボランティアとして参加する意欲を減退させたことが明らかになったのです。
この調査は、UCI MINDとして知られるUCI Institute for Memory Impairments and Neurological Disordersが実施したものです。Journal of Alzheimer’s Diseaseに掲載されました。

<関連情報>

アデュカヌマブの承認がアルツハイマー病の前臨床試験への参加意欲に与える影響について。Effect of Aducanumab Approval on Willingness to Participate in Preclinical Alzheimer’s Disease Trials

Ritchie, Marina | Witbracht, Megan | Nuño, Michelle M. | Hoang, Dan | Gillen, Daniel L. | Grill, Joshua D
Correspondence to: Marina Ritchie, MA, UC Irvine Institute for Memory Impairments and Neurological Disorders (UCI MIND), 3230 Biological Sciences III, University of California, Irvine, CA, USA.

Abstract:

Background:Clinical trials now test promising therapies in the preclinical stages of Alzheimer’s disease (AD). Participant willingness to enroll in different types of preclinical AD trials is understudied and whether the FDA approval of aducanumab affected these attitudes is unknown. Objective:To evaluate preferences toward three preclinical AD trial scenarios and whether the FDA approval of aducanumab changed willingness to participate among potential trial participants. Methods:Through an electronic survey, we asked enrollees in a recruitment registry age 50-79 to rate their willingness (using a 6-point Likert scale) to enroll in three hypothetical preclinical AD trial scenarios: an in-clinic infused monoclonal antibody intervention, a home-infused monoclonal antibody intervention, and an oral BACE inhibitor intervention. We administered the survey before and after the FDA approval of aducanumab. We used a generalized estimating equation model to assess group differences in preference for the trial scenarios. We used a paired t-test to determine if willingness to participate (using total willingness across three scenarios as the outcome) changed after the FDA decision. Results:At baseline, the mean participant willingness was highest in the in-clinic infusion scenario. There was no significant change in willingness to participate, overall, after the FDA decision. Participants who were independently aware of the FDA’s decision (prior to the second survey) demonstrated reduced willingness to participate; participants unaware of the FDA decision demonstrated no change. Conclusion:Willingness to participate in preclinical AD trials may have been negatively affected by the FDA’s decision to approve aducanumab among those aware of the decision.

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