A clinical trial was conducted to evaluate the safety and effectiveness of a drug called semorinemab in people with prodromal to mild Alzheimer's disease. This drug is a type of antibody that targets a protein called tau, which is involved in the development of Alzheimer's disease. The goal of this trial was to determine if semorinemab could slow down or stop the progression of Alzheimer's disease in its early stages.
The trial included 457 participants from North America, Europe, and Australia. The participants were between 50 and 80 years old, had prodromal to mild Alzheimer's disease, and had confirmed beta-amyloid pathology. Beta-amyloid is another protein that accumulates in the brains of people with Alzheimer's disease.
During the 73-week study period, the participants received either semorinemab or a placebo. The participants in the semorinemab group received either a low dose (1500 mg), a medium dose (4500 mg), or a high dose (8100 mg) of the drug. The drug was given to the participants through an intravenous infusion every two weeks for the first three infusions and every four weeks thereafter.
The primary goal of the trial was to see if semorinemab could slow down the progression of Alzheimer's disease. The researchers looked at two main things: changes in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score and changes in the amount of tau in the brain, as measured by a special imaging test called [18F]GTP1 tau positron emission tomography.
Unfortunately, the results of the trial were disappointing. The researchers found that the participants who received semorinemab did not show any significant difference in CDR-SB scores or tau accumulation compared to those who received the placebo. This means that semorinemab did not slow down the progression of Alzheimer's disease in these participants.