Zydena on Cognitive Function of Alzheimer's Disease Patients
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Placebo + Donepezil 5mg or 10mg
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Sponsored by
![Samsung Medical Center](https://trials-media.s3.amazonaws.com/orgs/samsung-medical-center.jpeg)
About this trial
This is an interventional treatment trial for Alzheimer's Disease
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®)
Sites / Locations
- Samguns Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Zydena 50mg
Placebo
Zydena 100mg
Arm Description
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Placebo + Donepezil 5mg or 10mg
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Outcomes
Primary Outcome Measures
Change in cognitive function
measured by ADAS-cog
Secondary Outcome Measures
Change in cognitive function
Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E
Change in behavioral symptoms
Measured by Neuropsychiatric Inventory
Change in brain function
Measured by FDG-PET
Full Information
NCT ID
NCT01940952
First Posted
September 9, 2013
Last Updated
September 9, 2013
Sponsor
Samsung Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01940952
Brief Title
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zydena 50mg
Arm Type
Active Comparator
Arm Description
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Donepezil 5mg or 10mg
Arm Title
Zydena 100mg
Arm Type
Active Comparator
Arm Description
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Intervention Type
Drug
Intervention Name(s)
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg
Other Intervention Name(s)
Zydena 50mg
Intervention Type
Drug
Intervention Name(s)
Placebo + Donepezil 5mg or 10mg
Other Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
Other Intervention Name(s)
Zydena 100mg
Primary Outcome Measure Information:
Title
Change in cognitive function
Description
measured by ADAS-cog
Time Frame
from baseline to Week 12 and Week 24 after the administration of the medication
Secondary Outcome Measure Information:
Title
Change in cognitive function
Description
Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E
Time Frame
from baseline to Week 12 and Week 24
Title
Change in behavioral symptoms
Description
Measured by Neuropsychiatric Inventory
Time Frame
from baseline to Week 12 and Week 24
Title
Change in brain function
Description
Measured by FDG-PET
Time Frame
from baseline to Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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®)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enda Go, Clinical Research Coordinator
Phone
82-2-3410-2868
Email
ed.ko@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Duk L. Na, MD. PhD
Phone
82-2-3410-3599
Ext
3599
Email
dukna@naver.com
Facility Information:
Facility Name
Samguns Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enda Go, Clinical Research Coordinator
Phone
82-2-3410-2868
Email
ed.ko@samsung.com
First Name & Middle Initial & Last Name & Degree
Duk L. Na, MD. PhD
12. IPD Sharing Statement
Learn more about this trial
Zydena on Cognitive Function of Alzheimer's Disease Patients
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