The Effect of Hydralazine on Early Stage Alzheimer’s Disease: A Randomized Clinical Trial (EHSAN)
Journal Title: The 2nd Annual Meeting of International Center for Neuroscience Research - Year 2021, Vol 2, Issue 1
Abstract
Objective: Hydralazine significantly delays the progression of Alzheimer's disease compared with placebo. Study population and sampling method: The study population in this study are all patients who have a possible diagnosis of Alzheimer's disease based on NINCDS-ADRDA. This randomized clinical trial will be conducted on 424 randomly selected patients over the age of 50 using random permuted blocks (each block consists of four participants) who are diagnosed with mild to moderate AD, after exclusion of dementia patients with etiologies other than AD (i.e. vascular related). This is a parallel double armed randomized clinical trials with allocation ratio of 1-1 to the intervention and placebo arms. The two arms of the study are Hydralazine 75mg (25mg three times per day) or Hydralazine placebo. Participants, outcome evaluators, researchers, and questioners will be blinded to the study arms. Screening phase: In the screening phase, the Mini-Mental State Examination (MMSE) and Palliativ Performance Scale (PPS) are taken, and then blood pressure, ECG, and blood tests are taken from the patient. Study phase: In this phase, the patient will answer the Alzheimer's Disease Assessment Scale (ADAS-cog) with the help of psychologist and the caregiver will complete the Neuropsychiatric Inventory (NPI), the Caregiver Activity Survey (CAS), and the Lawton Instrumental Activities of Daily Living (IADL) Scale with another psychologist. Follow up: All randomized patients are followed up in the clinic every 3 months (average follow-up 1 year).
Authors and Affiliations
Masoud Mirzaei and Nastaran Ahmadi*
Keywords
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