Published 4 October 2022 at 08.51
Domestic. Preliminary results of a clinical so-called phase III study show that the antibody lecanemab significantly slows the deterioration in patients with early Alzheimer's disease
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– If the antibody is approved as a drug, it could mean a real breakthrough for treatment early after the onset of the disease. Being able to slow the progression of the disease would save patients and relatives a lot of suffering, says Lena Kilander, senior physician and professor of geriatrics, Akademiska sjukhuset/Uppsala University.
Alzheimer's disease accounts for approximately 60 percent of all cases of dementia. The disease causes brain tissue to be gradually destroyed as nerve cells begin to wither and die to an abnormal extent. This leads to deterioration of memory and cognitive skills, such as intellectual ability, language, orientation, recognition and learning ability.
Unlike previous therapies, this antibody targets the process that causes the disease rather than the symptoms. It has been developed to reduce the amount of harmful amyloid beta in the brain; a misfolded protein believed to cause the disease. The antibody, which was originally called BAN2401, has been developed by a research group in molecular geriatrics at the Rudbeck Laboratory in Uppsala, led by Professor Emeritus Lars Lannfelt.
The current phase III study (CLARITY) has been conducted globally. A total of four Swedish university hospitals have participated in which memory wards recruited patients with early disease: Academic Hospital, Karolinska University Hospital in Huddinge, Sahlgrenska University Hospital in Gothenburg and Skåne University Hospital in Malmö. 1,795 patients with early Alzheimer's disease have been included and either received lecanemab or placebo.
– In the group that received lecanemab, the clinical deterioration on the global cognitive and functional scale CDR-SB decreased by 27 percent after 18 months of treatment.
Based on the results so far, the effect on cognition and functions is comparable to today's drugs, so-called cholinesterase inhibitors. The big advantage is that lecanemab has a disease-modifying effect, not just symptom relief. The preparation can thus provide a greater effect in long-term treatment over several years, says Lena Kilander in a dispatch.
All results will be presented at an Alzheimer's Congress in the USA on November 29 and then reviewed by experts and published in a scientific journal.
– Then we will also find out if the preparation is particularly effective in certain individuals, for example, those who have a specific risk gene for Alzheimer's that interacts with amyloid-beta. The risk of side effects in the form of brain edema has been shown to be low (2.8 percent). In the study, the antibody was given as an intravenous infusion every two weeks. This is both costly and impractical. Studies are underway, where the drug is administered less often and eventually the effect of subcutaneous injections will also be evaluated, says Lena Kilander.
The American pharmaceutical authority FDA is expected to give notice in January 2023 and marketing authorization in the EU and Japan is to be granted into the first quarter of 2023. According to Lena Kilander, it will likely take until the latter part of 2024 before it is known whether the drug will be registered for clinical use in Europe. After that, the Dental Care and Pharmaceutical Benefits Agency (TLV) must make its assessment.