Zydena on Cognitive Function of Alzheimer's Disease Patients

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg; Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg; Drug: Placebo + Donepezil 5mg or 10mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01940952

2012-03-065 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether Zydena (Udenafil) has positive effect on cognitive function in patients with Alzheimer's disease.

This study is a randomized, double blind, placebo-controlled multicenter study.

Enrollment: 210 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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®)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

Zydena 50mg

Active Comparator group

Description:

Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg

Treatment:

Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg

Placebo

Placebo Comparator group

Description:

Placebo + Donepezil 5mg or 10mg

Treatment:

Drug: Placebo + Donepezil 5mg or 10mg

Zydena 100mg

Active Comparator group

Description:

Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg

Treatment:

Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg