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Effect of Hydralazine on Alzheimer's Disease

NCT04842552 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2022-01-06

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Hydralazine hydrochloride 25mg tablets

Hydralazine hydrochloride 25mg tablets three time daily for 365 days (one year)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Institute for Medical Research Development (NIMAD)

    collaborator UNKNOWN

  • McMaster University

    collaborator OTHER

  • Shahid Sadoughi University of Medical Sciences and Health Services

    lead OTHER

Principal Investigators

  • Hamid Mirzaei, PhD · Shahid Sadoughi University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2023-06-01
Completion
2023-12-20
FDA Drug
Yes

Countries

  • Iran

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842552 on ClinicalTrials.gov