A Randomized Clinical Trial on Hydralazine for Early-Stage Alzheimer’s Disease: The EHSAN Study
Overview
Alzheimer’s Disease (AD) is a growing global issue with no cure available. Current treatments only help with symptoms. Hydralazine, a medication for high blood pressure, has shown promise in animal studies for protecting brain cells and improving their function. However, we need to confirm its effectiveness in humans.
Study Design
This ongoing study is a randomized, triple-blind, placebo-controlled trial. We aim to evaluate how hydralazine affects cognitive function in patients with mild to moderate AD. We will include 424 patients aged 50 and older, who meet specific criteria for AD. Participants will be randomly assigned to receive either:
- Hydralazine HCL (25 mg, three times daily)
- Placebo
The treatment will last for 12 months.
Outcomes
The main goal is to measure changes in cognitive function using the Alzheimer’s Disease Assessment Scale. We will also look at:
- Daily living activities
- Neuropsychiatric symptoms
- Caregiver experiences
Significance
This is the first trial to study hydralazine’s effects on humans with mild to moderate AD. The study is registered with the Iranian Registry of Clinical Trials and ClinicalTrials.gov, and has received ethical approval.
Limitations
Some limitations include:
- The study group may be too similar, affecting results.
- We are not using specific biomarkers for diagnosis.
- We cannot assess long-term effects beyond 12 months.
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