Alzheimer's Disease
Conditions
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.
Interventions
DRUGZydena (Udenafil) 50mg + Donepezil 5mg or 10mg
DRUGPlacebo + Donepezil 5mg or 10mg
DRUGZydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Sponsors
Dong-A Pharmaceutical Co., Ltd.
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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®)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | from baseline to Week 12 and Week 24 after the administration of the medication | measured by ADAS-cog |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactEnda Go, Clinical Research Coordinator
Backup ContactDuk L. Na, MD. PhD
Outcome results
None listed