First patient enrolled in phase 2b trial of novel therapy for mild Alzheimer’s

The first patient has been enrolled in a European phase 2b clinical trial for AD04, a novel immunotherapy for the treatment of mild Alzheimer’s disease, according to the manufacturer.

According to a press release from ADvantage Therapeutics, the 12-month, randomized, double-blind, placebo-controlled trial is expected to confirm proof-of-concept and establish safety and efficacy of AD04. The study, whose first patient was enrolled at Institut Neuromed in Korneuburg, Austria, has also been authorized to be conducted in France, Poland, Bulgaria and Slovakia, and is expected to expand to Germany and the United Kingdom in the near future.

The study’s primary endpoint will be a composite score integrating the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAScog), Alzheimer’s Disease Cooperative Study – Activities of Daily Living Standards (ADCS-ADL) and Clinical Dementia Rating-Sumsof Boxes (CDR-sb) at 6 months, the company said.

In a previous study, a 2 mg dose of AD04 administered in a control arm exhibited a “statistically significantly” slower decline in cognitive and quality of life measures compared with other arms in the trial, ADvantage Therapeutics said in the release. The AD04 control group additionally demonstrated slower decline in MRI-measured hippocampal volume as a biomarker of AD progression.

“Inclusion of this first patient follows many years and many dedicated professionals collaborating toward the common goal of better treating Alzheimer’s disease,” ADvantage chief medical officer Achim Schneeberger, MD, said in the release. “We look forward to continuing our collaboration with the European regulatory agencies and the clinical sites to populate this important trial.”