On 8 February, GSK and Alector announced the initation of the global PROGRESS-AD Phase II clinical trial of AL101 (also named GSK4527226) in people with early Alzheimer’s disease (AD) including mild cognitive impairment and mild dementia due to AD. The first participant has been dosed in the trial, which is expected to enoll approximately 280 participants in US, Canada and Europe. PROGRESS-AD is a 76-week randomised, double-blind and placebo-controlled Phase II clinical trial evaluating the efficacy and safety of two doses of AL101 in early AD.
Participants will receive either the experimental drug or placebo via an intravenous infusion. The primary endpoint of the study is the progression of cognitive impairment as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB). The trial also evaluates other clinical and functional outcome assessments such as cognition, memory and activities of daily living. AL101 has been shown to be generally well tolerated and elevated progranulin levels in healthy volunteers. Alector and GSK are co-developing and will be co-commercialising AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.
