Zydena on Cognitive Function of Alzheimer's Disease Patients

Phase 3

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo + Donepezil 5mg or 10mg; Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg; Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg

• Registration Number: NCT01940952
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Last Update Submitted: 2013-09-09
• Study First Posted: 2013-09-12
• Last Update Posted: 2013-09-12
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

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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®)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
Zydena 50mg	Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg	Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg

Primary Outcome Measures

Name	Time	Method
Change in cognitive function	from baseline to Week 12 and Week 24 after the administration of the medication	measured by ADAS-cog

Secondary Outcome Measures

Name	Time	Method
Change in cognitive function	from baseline to Week 12 and Week 24	Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E
Change in behavioral symptoms	from baseline to Week 12 and Week 24	Measured by Neuropsychiatric Inventory
Change in brain function	from baseline to Week 12 and Week 24	Measured by FDG-PET

Trial Locations

Locations (1)

Samguns Medical Center; 🇰🇷 Seoul, Korea, Republic of