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Hydralazine hydrochloride 25mg tablets / Alzheimer Disease · Phase 3 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 3 randomized controlled trial of hydralazine versus placebo in early-stage Alzheimer's disease patients on background acetylcholinesterase inhibitor therapy. No efficacy results are posted in this registry record, making it impossible to assess whether the intervention produced a clinical benefit.
Phase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Alzheimer Disease; age from 50 Years. Intervention: Hydralazine hydrochloride 25mg. Compared with: Placebo — Placebo Comparator. n = 228. 1 site: Iran.
This is a completed Phase 3 randomized controlled trial of hydralazine versus placebo in early-stage Alzheimer's disease patients on background acetylcholinesterase inhibitor therapy. No efficacy results are posted in this registry record, making it impossible to assess whether the intervention produced a clinical benefit.
No results are posted in this registry record; efficacy and safety outcomes are not reported. No adverse event data, dropout rates, or adherence metrics are provided in the registry record.
The source did not state who this applies to in practice.
This is a completed Phase 3 trial registration with no results posted; the registry record describes design and rationale only, precluding any evidence assessment of efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04842552). This is a study registration, not published results. Lead sponsor: Shahid Sadoughi University of Medical Sciences and Health Services. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 228 participants (ACTUAL). Conditions: Alzheimer Disease. Interventions: DRUG: Hydralazine hydrochloride 25mg tablets; DRUG: Placebo. Primary outcome measures: Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score from Baseline , Baseline, and Months 3, 6, 9, and 12. Brief summary: It has been recently discovered that the FDA-approved drug, hydralazine, has anti-neurodegenerative efficacy based on three intriguing observations. hydralazine; 1) activates the Nrf2 pathway that controls more than 200 antioxidant proteins, 2) rejuvenates mitochondria and increases their respiration capacity and adenosine triphosphate production, 3) activates autophagy which has pathophysiological roles such as intracellular aggregate clearance. There is an emerging agreement that autophagy-lysosome defects occur early in the pathogenesis of Alzheimer's disease (AD). Nrf2 is another pathway known to be impaired in the hippocampus of AD patients who need antioxidant protection the most. Rejuvenation of mitochondria is crucial for fighting AD, as neuronal cells need more energy to afford activation of pathways such as autophagy and Nrf2. The prime objective of this application is to conduct a randomized clinical trial to assess the efficacy of hydralazine in early-stage AD patients who take one of the acetylcholinesterase inhibitor (AChEI) donepezil, rivastigmine, or galantamine.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.