Article ; Online: Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab.
Alzheimer's & dementia : the journal of the Alzheimer's Association
2024 Volume 20, Issue 5, Page(s) 3406–3415
Abstract: Introduction: Aducanumab selectively targets aggregated forms of amyloid beta (Aβ), a neuropathological hallmark of Alzheimer's disease (AD).: Methods: PRIME was a Phase 1b, double-blind, randomized clinical trial of aducanumab. During the 12-month ... ...
Abstract | Introduction: Aducanumab selectively targets aggregated forms of amyloid beta (Aβ), a neuropathological hallmark of Alzheimer's disease (AD). Methods: PRIME was a Phase 1b, double-blind, randomized clinical trial of aducanumab. During the 12-month placebo-controlled period, participants with prodromal AD or mild AD dementia were randomized to receive aducanumab or placebo. At week 56, participants could enroll in a long-term extension (LTE), in which all participants received aducanumab. The primary endpoint was safety and tolerability. Results: Amyloid-related imaging abnormalities-edema (ARIA-E) were the most common adverse event. Dose titration was associated with a decrease in the incidence of ARIA-E. Over 48 months, aducanumab decreased brain amyloid levels in a dose- and time-dependent manner. Exploratory endpoints suggested a continued benefit in the reduction of clinical decline over 48 months. Discussion: The safety profile of aducanumab remained unchanged in the LTE of PRIME. Amyloid plaque levels continued to decrease in participants treated with aducanumab. Highlights: PRIME was a Phase 1b, double-blind, randomized clinical trial of aducanumab. We report cumulative safety and 48-month efficacy results from PRIME. Amyloid-related imaging abnormalities-edema (ARIA-E) were the most common adverse event (AE); 61% of participants with ARIA-E were asymptomatic. Dose titration was associated with a decrease in the incidence of ARIA-E. Aducanumab decreased levels of amyloid beta (Aβ) in a dose- and time-dependent manner. |
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MeSH term(s) | Humans ; Double-Blind Method ; Antibodies, Monoclonal, Humanized/therapeutic use ; Alzheimer Disease/drug therapy ; Male ; Female ; Aged ; Amyloid beta-Peptides/metabolism ; Brain/diagnostic imaging ; Brain/drug effects ; Brain/pathology ; Treatment Outcome ; Plaque, Amyloid/drug therapy ; Dose-Response Relationship, Drug |
Language | English |
Publishing date | 2024-04-03 |
Publishing country | United States |
Document type | Journal Article ; Randomized Controlled Trial ; Clinical Trial, Phase I |
ZDB-ID | 2211627-8 |
ISSN | 1552-5279 ; 1552-5260 |
ISSN (online) | 1552-5279 |
ISSN | 1552-5260 |
DOI | 10.1002/alz.13755 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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