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UnknownPhase 3

Effect of Hydralazine on Alzheimer's Disease

The Effect of Hydralazine on the Early Stage of Alzheimer's Disease: A Randomized Clinical Trial

Asset

Hydralazine hydrochloride

Listed sites

1

Recruiting sites

1

Enrollment

424

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE 12-26

Primary endpoint

•Progression of of Alzheimer's disease

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIRCT20200711048075N1
NCT IDNCT04842552

Timeline

Milestones

Study first posted2021-04-13actual
Study start2021-08-02actual
Last update posted2022-01-06actual
Primary completion2023-06-01estimated
Study completion2023-12-20estimated

Assets

Drug assets

Hydralazine hydrochloride

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age49 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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.

Endpoints (28)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
16
Global cognition
4
Behavior / neuropsychiatric
4
Caregiver / quality of life
4

Global cognition

4 endpoints
Secondary/protocol endpoint

Cognition of patients with Alzheimer's disease

Time frame:Three months after recruitment

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Cognition of patients with Alzheimer's disease

Time frame:Six months after recruitment

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Cognition of patients with Alzheimer's disease

Time frame:Nine months after recruitment

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Cognition of patients with Alzheimer's disease

Time frame:Twelve months after recruitment

Mini-Mental State Examination (MMSE)

descriptive

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

Behavior of patients with Alzheimer's disease

Time frame:Three months after recruitment

descriptive

Secondary/protocol endpoint

Behavior of patients with Alzheimer's disease

Time frame:Six months after recruitment

descriptive

Secondary/protocol endpoint

Behavior of patients with Alzheimer's disease

Time frame:Nine months after recruitment

descriptive

Secondary/protocol endpoint

Behavior of patients with Alzheimer's disease

Time frame:Twelve months after recruitment

descriptive

Caregiver / quality of life

4 endpoints
Secondary/protocol endpoint

Caregiver's spent time

Time frame:Three months after recruitment

descriptive

Secondary/protocol endpoint

Caregiver's spent time

Time frame:Six months after recruitment

descriptive

Secondary/protocol endpoint

Caregiver's spent time

Time frame:Nine months after recruitment

descriptive

Secondary/protocol endpoint

Caregiver's spent time

Time frame:Twelve months after recruitment

descriptive

Other (unclassified)

16 endpoints
Primary/protocol endpoint/low confidence

The progression of of Alzheimer's disease

Time frame:Three months after recruitment.

descriptive

Primary/protocol endpoint/low confidence

The progression of of Alzheimer's disease

Time frame:Six months after recruitment.

descriptive

Primary/protocol endpoint/low confidence

The progression of of Alzheimer's disease

Time frame:Nine months after recruitment.

descriptive

Primary/protocol endpoint/low confidence

The progression of of Alzheimer's disease

Time frame:Twelve months after recruitment.

descriptive

Secondary/protocol endpoint/low confidence

Function of patients with Alzheimer's disease

Time frame:Three months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Function of patients with Alzheimer's disease

Time frame:Six months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Function of patients with Alzheimer's disease

Time frame:Nine months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Function of patients with Alzheimer's disease

Time frame:Twelve months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Olfactory sense

Time frame:Three months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Olfactory sense

Time frame:Six months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Olfactory sense

Time frame:Nine months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Olfactory sense

Time frame:Twelve months after recruitment

descriptive

Secondary/protocol endpoint/low confidence

Drug side effects

Time frame:Daily records in the provided notebook and reported three month after recruitment. Urgent matter can be reported any time to the provided hotline.

descriptive

Secondary/protocol endpoint/low confidence

Drug side effects

Time frame:Daily records in the provided notebook and reported six month after recruitment. Urgent matter can be reported any time to the provided hotline.

descriptive

Secondary/protocol endpoint/low confidence

Drug side effects

Time frame:Daily records in the provided notebook and reported nine month after recruitment. Urgent matter can be reported any time to the provided hotline.

descriptive

Secondary/protocol endpoint/low confidence

Drug side effects

Time frame:Daily records in the provided notebook and reported twelve month after recruitment. Urgent matter can be reported any time to the provided hotline.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.