Status:
UNKNOWN
Effect of Hydralazine on Alzheimer's Disease
Lead Sponsor:
Shahid Sadoughi University of Medical Sciences and Health Services
Collaborating Sponsors:
National Institute for Medical Research Development (NIMAD)
McMaster University
Conditions:
Alzheimer Disease
Eligibility:
All Genders
49+ years
Phase:
PHASE3
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 con...
Detailed Description
Study aim: 1. Determination and comparison of the effect of 75mg (25mg TDS) hydralazine vs. placebo in patients with mild to moderate Alzheimer's disease. 2. Development of an electronic Case Report ...
Eligibility Criteria
Inclusion
- Diagnoses of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Presence of a caregiver (friend or relative) who can assume responsibility for medication administrations, accompany the patient to all visits, and rate patient's condition.
- Written informed consent form from both the patient (or surrogate) and caregiver.
- A Mini-Mental State Examination score between 12 and 26 inclusive.
- Prescription of donepezil (5-10mg/d), rivastigmine (3-6mg/d), galantamine or galantamine ER (8-16mg/d) for a minimum of 4 weeks prior to randomization.
- Agreement not to take hydralazine.
- Age 49 and over.
Exclusion
- Non-Alzheimer primary dementia diagnosis (e.g., vascular dementia, Lewy body dementia, frontotemporal dementia, vitamin B-12 deficiency, hypothyroidism).
- Diagnosis of any of the following conditions; major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by Diagnostic and Statistical Manual (DSM)-IV.
- Diagnosis of systemic illnesses that would interfere with participation in the study or decrease the life expectancy to less than one year.
- Currently being treated with hydralazine or a history of intolerance to oral therapy with hydralazine
- Any intravenous treatment for heart failure, except IV furosemide (e.g. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.
- Systolic blood pressure \<100 mmHg, reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction-over the past 4 weeks, arrhythmia and existence of pacing device (Acute myocardial infarction is defined as symptoms and major electrocardiogram (ECG) changes (i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min).
- Existence of severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta) and severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.
- Concurrent use of phosphodiesterase type 5 (PDE5) inhibitors (e.g. Viagra, Etc.)
- Cardiac revascularization within the last 3 months or likelihood of requiring coronary revascularization within the study period. eGFR (Glomerular Filtration Rate) \< 15ml/min/1.73m2, or on regular dialysis, or planned dialysis within the study period.
Key Trial Info
Start Date :
August 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2023
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT04842552
Start Date
August 2 2021
End Date
December 20 2023
Last Update
January 6 2022
Active Locations (1)
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1
Adineh Health Centre
Yazd, Iran, 8916713151