The active substance aducanumab was tested in two large phase III trials. Based on new positive efficacy data, the study program, which has been suspended in the meantime, will be continued.
The active substance aducanumab was tested in two large phase III trials. Based on new positive efficacy data, the study program, which has been suspended in the meantime, will be continued.
The phase IIIb open-label study launched by the pharmaceutical company Biogen is listed in the official clinical trials databases (ClinicalTrials.gov). The sample includes 2400 Alzheimer’s patients who were previously treated with aducanumab as subjects. Study participants will receive monthly injections over a two-year period. The primary endpoints relate to safety and tolerability of the agent. The study is based on evaluations of the phase III EMERGE and ENGAGE trials. After initially declaring the project goals a failure, data analyses including all subjects in October 2019 revealed evidence of efficacy. Study participants from the EMERGE trial who received aducanumab at the highest dose showed a slightly smaller decline in performance on neuropsychological tests than the placebo group. On the Clinical Dementia Rating (CDR-SB) test, the high-dose subjects deteriorated 22% less than the placebo group after 78 weeks. In the Mini-Mental Status Test (MMST), this value was 18%. Biogen announced in the last quarter of last year that an application for approval of aducanumab would initially be filed in the United States. The FDA (US Food and Drug Administration) decides on this. Biogen also plans to negotiate with European regulatory authorities.
Alzheimer’s disease is a neurodegenerative disease with progressive cognitive impairment and often leads to an increasing limitation of the independence of affected persons. There are over 40 million people affected by Alzheimer’s worldwide, and the trend is increasing. Aducanumab targets beta-amyloid, a protein characteristic of Alzheimer’s disease. This consists of deposits in the brain, which are associated with the destruction of nerve cells. The active ingredient aducanumab has so far been tested exclusively in patients at an early stage of the disease, who so far have only minor losses in their mental capacity. Currently, there are no drugs on the market in the drug therapy of Alzheimer’s disease that act on the basic mechanisms of the disease. The currently available preparations only stimulate brain performance or treat concomitant symptoms.
Source: https://clinicaltrials.gov
GP PRACTICE 2020; 15(3): 42
