The progression of Alzheimer's disease was slowed down by immunotherapy
Oleg Lischuk, N+1
American and Swiss scientists have reported the success of early clinical trials of a biopreparation that slows down the development of Alzheimer's disease. The report on the work was published in the journal Nature (Sevigny et al., The antibody aducanumab reduces Aß plaques in Alzheimer's disease).
Alzheimer's disease is the most common neurodegenerative disease and the leading cause of dementia (acquired dementia) in the world. According to modern concepts, neurodegeneration is caused by the accumulation of two pathological forms of proteins in the brain: beta-amyloid (in the form of plaques) and hyperphosphorylated tau protein (in the form of neurofibrillary tangles). Previous attempts to control the synthesis or excretion of beta-amyloid have not led to significant success.
The new drug aducanumab, developed by Biogen and Neurimmune, is a monoclonal human antibody that selectively binds to soluble and insoluble forms of beta-amyloid and promotes their removal from the nervous tissue. The origin of these antibodies deserves special attention – they were found in elderly people with natural resistance to the development of Alzheimer's disease.
165 patients with an early stage of the disease participated in phase Ib clinical trials (aimed at clarifying the safety, tolerability, pharmacokinetics, pharmacodynamics and optimal dosage of the drug). They were given different doses of aducanumab or placebo every month for a year. Beta-amyloid deposits in the brain were visualized by PET scanning, and the progression of symptoms was assessed using the dementia and mental status scales CDR-SB and MMSE.
It turned out that aducanumab dose-dependent reduced the accumulation of beta-amyloid in the brain of patients, and also slowed down, albeit slightly, the progression of cognitive impairment. At the same time, the frequency of side effects turned out to be quite high: because of them, 20 patients were forced to prematurely terminate their participation in the trials. Micro-hemorrhages and edema of brain tissue were most often observed, which passed by themselves after 4-12 weeks.
Reduction of beta-amyloid deposits in the brain
under the influence of different doses of the drug (figure from the article in Nature)
According to the authors of the work, the results obtained should be approached with caution – the small scale of pilot tests does not allow us to draw unambiguous conclusions about the effectiveness and safety of the drug. Convincing data should be obtained during two large one-and-a-half-year phase III trials, which are currently underway and include 2,700 participants.
Recently, a different approach to drug therapy for Alzheimer's disease has yielded positive results. The drug LMTX, which prevents the formation and accumulation of tangles of tau protein, slowed the progression of dementia by about 80 percent in phase III clinical trials. Interestingly, this effect was observed only in patients who did not take other drugs for Alzheimer's disease.
Another research team reported that they managed to reverse the decline in intelligence in 10 patients with early stages of the disease by optimizing metabolism according to a specially developed MEND protocol.
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02.09.2016