Hydralazine

The EHSAN phase three clinical trial, adhering to the CONSORT statement, evaluates hydralazine's effect on cognitive function in mild to moderate AD patients over 52 weeks, comparing it to a placebo. The trial, involving 424 patients at Adineh Health Clinic, Iran, follows the SPIRIT protocol. Assessments include cognitive evaluations using the ADAS-cog, physical health assessments, and monitoring for adverse events. Inclusion criteria require patients to be 50 years or older, diagnosed with mild to moderate AD, and have a consistent caregiver. Exclusion criteria focus on non-AD primary dementia and other conditions that may confound results. The intervention involves hydralazine or placebo, with randomization stratified by age, sex, and MMSE score. The primary outcome measure is the ADAS-cog, with secondary measures including the Lawton Instrumental Activities of Daily Living Scale, Neuropsychiatric Inventory, and Caregiver Activity Survey. The trial emphasizes strict protocol adherence and safety monitoring through the Data and Safety Monitoring Committee.