About Pricing FAQs Providers Trials Blog

Back to your record

Login Get started

Finding studies

Your health journey, clearly organized.

Questions? feedback@clareohealth.com

Product

How it works
Pricing
For Providers
Trials

Company

About
Blog
FAQ

Legal

Privacy Policy
Terms of Service

© 2026 Clareo Health. All rights reserved.

Zydena on Cognitive Function of Alzheimer's Disease Patients

NCT01940952·1 site·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Enda Go, Clinical Research Coordinator
CONTACT
82-2-3410-2868 ed.ko@samsung.com
Duk L. Na, MD. PhD
CONTACT
82-2-3410-3599 dukna@naver.com

Lead

Samsung Medical Center

With

Dong-A Pharmaceutical Co., Ltd.

Age

50–90

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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®)

The record

StatusUnknown

PhasePhase 3

Taking part210

StartedSep 2013

UpdatedSep 12, 2013

Conditions

Alzheimer's Disease

Where1

Samguns Medical Center
Seoul, South Korea