On 27 November, ADvantage Therapeutics, a company developing therapies to treat neurodegenerative conditions with a central focus on Alzheimer’s disease (AD) announced the start of its Phase IIb clinical trial in Europe investigating AD04 for the treatment of mild AD. AD04, the company's lead candidate, has been used as an adjuvant in human and animal vaccination programs. In a previous study, a 2mg dose of AD04 used in a control arm exhibited a statistically significantly slower decline in cognitive and quality of life measures compared to other arms of that trial.
The Phase IIb randomised, double-blind and placebo-controlled trial aims to confirm proof-of-concept and establish the safety and efficacy of AD04 in people with mild AD. Participants are randomly assigned to receive either AD04 or a placebo for one year. The primary endpoint of the study is to evaluate changes in cognitive function at 12 months using a composite score that integrates the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) and the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
Other measured outcomes include hippocampal volume, the Neuropsychiatric Inventory (NPI) and the patient quality of Life-Alzheimer’s disease. The study is authorised to be conducted in Austria, France, Poland, Bulgaria and Slovakia, and is expected to expand to Germany and the UK in the coming months. The first participant was enrolled in Austria.
