Clinical trials have shown a decrease in the progression of Alzheimer's disease by more than half
Phase III clinical trials in patients with mild to moderate Alzheimer's disease more than halved the progression of the disease. Therapy included removal of β-amyloid from the blood, and not from the brain. Amyloid-β levels are dynamic, and there is a balance between its amount in the brain and in the blood. Past tests have shown that a decrease in the level of β-amyloid in the blood can reduce its presence in the brain, which is the result of a new balance.
The test seems to be an important confirmation of the amyloid hypothesis of Alzheimer's disease, just at the time of its intense criticism. The history of unsuccessful attempts to reduce the level of β-amyloid has led to a variety of competing initiatives and increased attention to tau-aggregation as the main cause of pathology in the later stages of the disease. I also see some signs in the test in favor of the concept of impaired CSF filtration in the brain . In it, the ways in which CSF leaves the brain atrophy with age, and the rate of metabolic debris removal decreases.
Alzheimer Management by Albumin Replacement (AMBAR) is an international, multicenter, randomized , blind, a placebo-controlled , parallel, group clinical trial in which patients with mild to moderate Alzheimer's disease from 41 centers in Europe and the United States participated. The aim of the test was to evaluate the effectiveness and safety of short-term plasma replacement , and then long-term plasmapheresis with human albumin injections in combination with intravenous immunoglobulin infusion in patients with mild to moderate Alzheimer's disease.
AMBAR is based on the hypothesis that most of the β-amyloid accumulated in the brain of Alzheimer's patients is bound to albumin and circulates in plasma. Extraction of this plasma can lead to the migration of β-amyloid from the brain to plasma, which reduces the effect of the disease on the patient's cognitive functions. In addition, albumin can be a comprehensive approach to treating a disease due to its binding ability, antioxidant, immunomodulatory and anti-inflammatory properties.
The AMBAR trial included 496 patients with mild to moderate Alzheimer's disease randomized in three treatment groups and one placebo group.. Participants were 55–85 years old, and treatment effectiveness was measured by changes in cognition and in indicators of daily life. An independent research organization (CRO) supervised the clinical trial and the steps of collecting and analyzing information. The trial used randomized and double-blind control , which meant that patients, doctors, and testers did not know if the patients were using treatment or placebo.
AMBAR analyzes showed positive, very relevant results in patients with mild Alzheimer's disease. Doctors found a 50–75% reduction in progression in the cognitive Alzheimer's Disease Rating Scale ( ADAS-Cog ) and 42–70% reduction in the daily life scoring score ( ADCS-ADL) in patients receiving treatment. Including all patients receiving plasma replacement, the difference was 66% on the ADAS-Cog scale and 52% on the ADCS-ADL scale.