Clinical
Trial background and the US regulatory approach.
Two distinct things, kept distinct: a completed academic trial that NeuroNova did not sponsor, and a US registrational program that has not yet begun.
Hydralazine is an investigational treatment for Alzheimer’s disease. It has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for this use. Its safety and effectiveness for Alzheimer’s disease have not been established.
The EHSAN trial — completed, investigator-initiated
A randomized controlled trial of hydralazine was conducted by investigators at Shahid Sadoughi University of Medical Sciences, Yazd, Iran, on which our founder served as Study Chair. The study protocol is peer-reviewed and published in Scientific Reports.
- Registration
- NCT04842552 · IRCT20200711048075N1
- Design
- Single-center, randomized, triple-blind, placebo-controlled; 52-week treatment period
- Population
- Mild to moderate Alzheimer’s disease (MMSE 12–26)
- Regimen
- Oral hydralazine hydrochloride 25 mg three times daily versus matched placebo, adjunctive to acetylcholinesterase-inhibitor therapy
- Primary endpoint
- Change from baseline in ADAS-Cog over 12 months
- Sponsor
- Shahid Sadoughi University of Medical Sciences and Health Services
- Status
- The study has completed its 52-week follow-up period. Results have not been published.
NeuroNova is not the sponsor of this trial and does not hold rights to its dataset. Nothing on this website reports, summarizes, or characterizes the trial’s results.
Note on the public registry record: the ClinicalTrials.gov entry for NCT04842552 predates the study’s completion and has not been updated since January 2022. Updates to the record rest with the trial’s sponsor.
Disclosure. NeuroNova’s founder and Chief Executive Officer, Hamid Harrison Mirzaei, PhD, served as Study Chair of the EHSAN trial and is an author of its published protocol. The trial’s Principal Investigator, Masoud Mirzaei, MD, PhD, is his brother. The trial was sponsored and conducted by Shahid Sadoughi University of Medical Sciences.
The planned US program
We have completed a pre-IND interaction with FDA and hold written Agency responses that define the requirements for a US registrational program. The planned registrational design follows the Agency’s written input on diagnosis and staging, endpoint structure, safety monitoring, and statistical pre-specification. The intended US indication is early Alzheimer’s disease.
Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act permits a new drug application to rely in part on existing published data for a previously approved drug. It is a statutory route, not a judgment by FDA about any program that uses it.
Statements on this page about future plans are forward-looking. See Forward-Looking Statements.