Alzheimer's disease development is again frustrated to terminate the Lanabecestat clinical phase 3 trial June 13, 2018 Source: Sina medicine Author: KERR On June 12, Eli Lilly and Company announced that it and AstraZeneca are discontinuing the global phase III clinical trial of oral beta-secretase lyase (BACE) inhibitor Lanabecestat for the treatment of Alzheimer's disease. The decision was based on the recommendations of the Independent Data Monitoring Committee (IDMC), which concluded that the early Alzheimer's disease trial AMARANTH and the trial for mild Alzheimer's disease dementia DAYBREAK-ALZ were unlikely to reach their primary endpoint. And therefore should stop. As a result of this decision, the AMARANTH expansion test will also stop. In the first half of 2018, large pharmaceutical companies around the world have terminated several new drug research and development projects, many of which are related to Alzheimer's disease (see: New drug projects that were smashed by pharmaceutical companies in the first half of 2018). The AMARANTH trial randomized patients with early Alzheimer's disease by oral administration of 20 mg or 50 mg of lanabecestat or oral placebo once daily for 104 weeks. The primary endpoint of the trial was baseline changes in 13 Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog13). A population of patients with mild cognitive impairment due to Alzheimer's disease and a patient diagnosed with mild Alzheimer's dementia is defined as early Alzheimer's disease. Patients who completed the AMARANTH trial had the opportunity to participate in the AMARANTH expansion trial. The DAYBREAK-ALZ trial enrolled patients with mild Alzheimer's disease dementia who were randomized to receive either 20 mg or 50 mg of lanabecestat or placebo once daily until 156 weeks. The primary endpoint of the trial was the baseline change in ADAS-Cog13. Alzheimer's disease is a deadly disease that causes a further decline in memory and cognitive ability. Dementia caused by the disease is the most common form of dementia, accounting for 60%-80% of all cases. An estimated 50 million people worldwide suffer from dementia. By 2030, the number is expected to increase to nearly 75 million and will increase to 132 million by 2050. Nearly 10 million new cases are diagnosed worldwide each year, which means that a new case will be diagnosed every 3 seconds. The annual estimated social and economic costs of dementia worldwide are $818 million, and may exceed $1 trillion in 2018. Daniel Skovronsky, MD, president of Eli Lilly Research Laboratories, said: "The complexity of Alzheimer's disease constitutes one of the toughest medical challenges of this era, and we are deeply disappointed that millions of people suffer from this devastating disease. We are very grateful to the participants and their families for their contributions and encourage them to consider other clinical trials of Alzheimer's disease. Lilly has been working on Alzheimer's disease research, and we have been working on it for the past 30 years. We will not give up the solution to find patients with Alzheimer's disease." IDMC's recommendation to stop the study is not based on security considerations. The Lilly and AstraZeneca BACE Alliances are still valid for lanabecestat, and the company will now discontinue the trial at a partner clinical trial site. Eli Lilly expects this decision to have no significant cost impact. Reference: Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimer's Disease Hook Lock,Device Red Hook Lock,Security Hook Lock,Anti-Theft Peg Hook Lock ZHEJIANG BOSHINE ELECTRONIC SECURITY CO.,LTD , https://www.boshine.com