Cognito Therapeutics has enrolled the first patient in a biomarker substudy within its HOPE pivotal trial evaluating sensory stimulation device in Alzheimer’s disease patients.
The HOPE study (NCT05637801) is assessing the efficacy of Cognitio’s GammaSense Stimulation system in subjects with mild to moderate Alzheimer’s disease. The randomised, double-blind, sham-controlled, adaptive-design trial aims to administer the therapy to 530 subjects with Alzheimer’s for 12 months.
The substudy will evaluate magnetic resonance imaging (MRI), cerebrospinal fluid and plasma biomarkers. The main study will measure the efficacy of Alzheimer’s disease tests such as Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
