Zydena on Cognitive Function of Alzheimer's Disease Patients
NCT ID: NCT01940952
Last Updated: 2013-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
210 participants
INTERVENTIONAL
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study is a randomized, double blind, placebo-controlled multicenter study.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zydena 50mg
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Placebo
Placebo + Donepezil 5mg or 10mg
Placebo + Donepezil 5mg or 10mg
Zydena 100mg
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Placebo + Donepezil 5mg or 10mg
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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®)
50 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Duk Lyul Na
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Samguns Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Enda Go, Clinical Research Coordinator
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-03-065
Identifier Type: OTHER
Identifier Source: secondary_id
2012-03-065
Identifier Type: -
Identifier Source: org_study_id