Scientists assessed the effectiveness of solanezumab in the preclinical stage of Alzheimer’s disease. The drug did not slow down the manifestation of clinical symptoms of the disease.
Researchers from Harvard Medical School, the Universities of Southern California, Tokyo and the University of Melbourne studied the effectiveness of the monoclonal antibody solanezumab in patients with early-stage Alzheimer’s disease without clinical symptoms. The study results were published in The New England Journal of Medicine.
The mean change in the Preclinical Alzheimer’s Disease Cognitive Impairment (PACC) score was comparable in both groups. When taking solanezumab, the score decreased by an average of 1.43 points, in the placebo group – by 1.13 points. Amyloid levels on follow-up positron emission tomography of the brain increased by an average of 11.6 centyloids in the group and by 19.3 centyloids in those taking placebo. Foci of pathological accumulation of amyloid with edema were observed in less than 1% of participants in each group, with microbleeds or hemosiderosis in 29.2% of participants in the solanezumab group and in 32.8% in the placebo group.
Data from 1,169 elderly people with preclinical Alzheimer’s disease were analyzed. The average age of the participants was 72 years. In all patients, the Global Clinical Assessment of Dementia Scale score was 0 out of three possible points, and the Mini-Mental Status Assessment score was 25 or higher. Also, all participants were found to have elevated levels of amyloid in the brain according to positron emission tomography with 18F-florbetapir.
Participants were almost equally divided into two groups: solanezumab up to 1600 mg intravenously every 4 weeks or placebo. After 6 months, changes in a composite measure of cognitive impairment in preclinical Alzheimer’s disease were assessed. A decrease in score indicated deterioration in cognitive function.
The study found that solanezumab did not slow cognitive decline compared with placebo over 6 months in people with preclinical Alzheimer’s disease.