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UnknownPhase 3

Zydena on Cognitive Function of Alzheimer's Disease Patients

Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study

Lead sponsor

Samsung Medical Center

Asset

Zydena (Udenafil)

Listed sites

Recruiting sites

Enrollment

210

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global ≥0.5•MMSE 10-26•AD symptomatic therapy: stable

Primary endpoint

•ADAS-Cog

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 ID2012-03-065

Secondary ID2012-03-065Samsung Medical Center

NCT IDNCT01940952

Timeline

Milestones

Study start2013-09 (month precision)

Study first posted2013-09-12estimated

Last update posted2013-09-12estimated

Primary completion2015-08estimated (month precision)

Assets

Drug assets

Zydena (Udenafil)

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Signed written informed consent;

•Male or female subjects 50 to 90 years of age;

•Diagnosis of probable Alzheimer's disease according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria;

•A Mini-Mental State Examination (MMSE) score of ≥10 and ≤26;

•Global Clinical Dementia Rating ≥ 0.5;

•Mild to moderate (not severe) white matter hyperintensities on brain MRI performed within three years from screening;

•Good enough hearing and visual function to complete neuropsychological tests

•Caregivers living with patients or spending 10 or more hours a week with patients;

•Stable dose of donepezil (5mg to 10mg) for at least 60 days;

•If patients have been on memantine, it should be washed out for at least 60 days;

•Medications including anxiolytics, antipsychotics, and hypnotics may be taken if the dose has been stable for at least two weeks

Exclusion criteria

•History of stroke within 6 months;

•Previous diagnosis of severe (more than 80%) intracranial artery stenosis;

•History of heart failure, ischemic heart disease (myocardial infarction, unstable angina, and stable angina), hypertrophic cardiomyopathy, and life-threatening arrhythmia;

•Previous history of coronary artery bypass graft surgery;

•Severe symptom of orthostatic hypotension (orthostatic syncope or presyncope), especially when patients take alpha-adrenergic blocker (Alfuzosin, Doxazosin, Naftopidil, Tamsulosin, Terazosin, Arotinolol, Carvedilol, Labetalol, Trazodone, typical and atypical antipsychotics);

•Uncontrolled diabetes mellitus;

•Proliferative diabetic retinopathy;

•Severe hypotension (blood pressure less than 90/50mmHg) or severe hypertension (blood pressure more than 170/100mmHg);

•Hepatic dysfunction (AST or ALT more than three times of upper normal limit) or renal dysfunction (serum creatinine more than 2.5mg/dL);

•Retinitis pigmentosa;

•Previous history of active peptic ulceration within one year before screening;

•Hematodyscrasia susceptible to priapism including sickle cell anemia, multiple myeloma, leukemia, and various bleeding disorders;

•History of drug abuse;

•Medication including nitrates/nitric oxide donor (ex: nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, and Sodium nitroprusside), androgen (ex: testosterone), anti-androgen, and anticoagulants;

•Current cancer chemotherapy;

•Usage of PDE5i (Zydena, Viagra®, Levitra®, or Cialis®) within two weeks before study start;

•History of hypersensitive reaction to PDE5i (Zydena, Viagra®, Levitra®, or Cialis®)

Endpoints (4)

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

Global cognition

Behavior / neuropsychiatric

Neuroimaging

Global cognition

2 endpoints

Primary/protocol endpoint

Change in cognitive function

Time frame:from baseline to Week 12 and Week 24 after the administration of the medication

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in cognitive function

Time frame:from baseline to Week 12 and Week 24

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change in behavioral symptoms

Time frame:from baseline to Week 12 and Week 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Change in brain function

Time frame:from baseline to Week 12 and Week 24

change from baseline, improvement

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.