Clinical trial NCT01940952: Zydena on Cognitive Function of Alzheimer's Disease Patients
Official title: Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2013-09-12
Enrollment: 210
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®)

Primary outcomes:
measure: Change in cognitive function
timeFrame: from baseline to Week 12 and Week 24 after the administration of the medication
Secondary outcomes:
measure: Change in cognitive function
timeFrame: from baseline to Week 12 and Week 24
measure: Change in behavioral symptoms
timeFrame: from baseline to Week 12 and Week 24
measure: Change in brain function
timeFrame: from baseline to Week 12 and Week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samguns Medical Center
Study officials:
References: