Tauriel was a Phase 2, randomised and placebo-controlled clinical trial that was conducted between October 2017 and July 2020 in North America, Europe and Australia, designed to test the safety and efficacy of semorinemab. On 14 July, the Tauriel investigators published topline results in JAMA Neurology, showing that treatment with semorinemab was not able to slow clinical progression of Alzheimer's Disease (AD) compared to placebo.
Semorinemab is an antibody that targets the human tau protein, which accumulates in tangles within the brain during the development of AD. Early-stage studies showed that the drug was effective in animal models of AD and had a favourable safety profile. The Tauriel study recruited over 400 participants from 97 sites across North America, Europe and Australia, randomising participants to receive placebo or one of three increasing doses of semorinemab. Participants, who had mild cognitive impairment or dementia due to AD, received a monthly dose of semorinemab via intravenous infusion, for a period of 73 weeks. Primary outcomes were change from baseline on the CDR-SB scale of cognition and function (CDR-SB: Clinical Dementia Rating - Sum of Boxes), adverse events and MRI assessment of brain structure.
The Tauriel study data revealed that participants who received semorinemab experienced similar increases in CDR-SB score as those receiving a placebo. This indicates that semorinemab treatment under the conditions of the trial was not able to slow disease progression. However, the trial confirmed that the drug had an acceptable and well-tolerated safety profile, similar to the results of earlier-stage trials.
To read the original article: https://jamanetwork.com/journals/jamaneurology/article-abstract/2793069