Zydena on Cognitive Function of Alzheimer's Disease Patients

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01940952
• Other study ID #: 2012-03-065
• Secondary ID: 2012-03-065
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 9, 2013
• Last updated: September 9, 2013
• Start date: September 2013

Study information

• Verified date: September 2013
• Source: Samsung Medical Center
• Contact: Enda Go, Clinical Research Coordinator
• Phone: 82-2-3410-2868
• Email: ed.ko[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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®)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

• Placebo + Donepezil 5mg or 10mg

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

Locations

Country	Name	City	State
Korea, Republic of	Samguns Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Dong-A Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function	measured by ADAS-cog	from baseline to Week 12 and Week 24 after the administration of the medication	No
Secondary	Change in cognitive function	Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E	from baseline to Week 12 and Week 24	No
Secondary	Change in behavioral symptoms	Measured by Neuropsychiatric Inventory	from baseline to Week 12 and Week 24	No
Secondary	Change in brain function	Measured by FDG-PET	from baseline to Week 12 and Week 24	No