Lecanemab, a medicine developed by Eisai, has been approved for use in the US to treat early-stage Alzheimer’s disease. Clinical trials are being conducted in Japan to assess the efficacy of Lecanemab and another medicine, E2814, in slowing down the cognitive decline caused by Alzheimer’s disease. The clinical trials will involve around 170 people globally, with 10 to 20 participants in Japan, who belong to families with a genetic predisposition to developing familial Alzheimer’s disease. The aim is to check whether these medicines can prevent or slow down the accumulation of amyloid beta and tau, which are responsible for Alzheimer’s disease. Familial Alzheimer’s disease is caused by genetic mutations and is usually developed during the peak of a patient’s career, making treatment highly desired.
Clinical Trials for Familial Alzheimer’s Drugs to Commence in 2023
Researchers from Niigata University and the University of Tokyo are set to initiate clinical trials this year on drugs intended to alleviate the effects of familial Alzheimer’s disease. The trial aims to tackle the accumulation of abnormal proteins in the brain, which scientists believe cause Alzheimer’s. The subjects for the trial will be individuals from families with a history of hereditary dementia, which can manifest in patients at a young age.
Niigata University has granted its approval for the study, while the University of Tokyo has granted its approval with the proviso that relevant documents are reviewed. The trial is part of an international joint clinical trial that will take place in 16 regions and countries.
Alzheimer’s disease occurs when the brain gradually accumulates proteins called amyloid beta and tau, which can damage nerve cells, causing the brain to shrink. This results in memory loss and impaired judgment among those who suffer from the disease.
Scientists have discovered that the accumulation of amyloid beta starts around 10 to 20 years before symptoms manifest and that the accumulation of tau follows after that. Familial Alzheimer’s disease, which causes patients to experience symptoms in their 40s to 50s, is typically caused by genetic mutations inherited from parents. The buildup of amyloid beta in familial Alzheimer’s disease starts between the ages of 20 and 30.
Studying familial Alzheimer’s disease could help elucidate the general mechanisms behind Alzheimer’s disease and lead to the development of treatments for the condition. With the aging of Japan’s population, the number of people suffering from Alzheimer’s disease is on the rise.
Subjects for the clinical trial will be selected from people participating in familial Alzheimer’s disease observation studies. The trial will include individuals with confirmed genetic mutations and their ages will range from ten years before the estimated onset of the disease to ten years after onset. The trial will cover people with mild symptoms and those without any symptoms.
All the subjects of the trial will receive three to four years of intravenous drips of Lecanemab, a drug that removes amyloid beta. Eisai Co., a leading Japanese pharmaceutical company, and its partners developed the medication.
Clinical Trials for Lecanemab and E2814 Medicines to Treat Alzheimer’s Disease
Lecanemab, a medicine developed by Eisai Co., was approved for use in the United States in January to treat patients with early-stage Alzheimer’s disease. Clinical trials are currently being conducted in Japan to assess its efficacy.
In addition to Lecanemab, half of the clinical trial’s subjects will receive E2814, another medicine developed by Eisai, to prevent tau from spreading inside their brains. The clinical tests will determine whether the medicines can help prevent or slow the decline of cognitive function by checking for changes in the quantity of amyloid beta and tau inside subjects’ brains.
Around 170 people globally, including 10 to 20 in Japan, are expected to participate in the clinical trials, which focus on people who belong to families with a predisposition to developing familial Alzheimer’s disease.
Familial Alzheimer’s disease is caused by genetic mutations, and research has discovered three types of genetic mutations that cause this form of Alzheimer’s. People have a 50% chance of inheriting the genetic mutations from their parents. As patients with familial Alzheimer’s disease typically develop the disease during the peak of their careers, there is a stronger desire for treatment. The clinical trials aim to confirm whether the medicines are effective and can be utilized to treat the general type of Alzheimer’s disease as well.
A nationwide survey conducted in fiscal 2013 among doctors specializing in dementia confirmed the existence of 987 patients in 434 family lines with familial Alzheimer’s disease.
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