Alzheimer's DiseasePhase 3NCT01940952
Zydena on Cognitive Function of Alzheimer's Disease Patients
A Phase 3 study testing Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg and Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg in people with Alzheimer's Disease, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg and Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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
Who cannot join
- 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;
Show all 17Show fewer
- 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®)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samguns Medical Center
Seoul, 135-710
Enda Go, Clinical Research Coordinator, 82-2-3410-2868, ed.ko@samsung.com
Duk L. Na, MD. PhD
About this study
Official title: Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study
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.
- Conditions
- Alzheimer's Disease
- Being tested
- Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg, Placebo + Donepezil 5mg or 10mg, Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zydena (Udenafil) 50mg + Donepezil 5mg or 10mgDrug
Also called Zydena 50mg
Placebo + Donepezil 5mg or 10mgDrug
Also called Placebo
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mgDrug
Also called Zydena 100mg
| Study group | Role | What they receive |
|---|---|---|
| Zydena 50mg | Active comparator | Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg Receives: Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg |
| Placebo | Placebo comparator | Placebo + Donepezil 5mg or 10mg Receives: Drug: Placebo + Donepezil 5mg or 10mg |
| Zydena 100mg | Active comparator | Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg Receives: Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
measured by ADAS-cog
Measured: from baseline to Week 12 and Week 24 after the administration of the medication
Secondary outcomes (3)
Change in cognitive function
Measured by MMSE, Clinical Dementia Rating Sum of Boxes, ADCS-ADL, COWAT, Digit Symbol Coding, Trail Making Test-E
Measured: from baseline to Week 12 and Week 24
Change in behavioral symptoms
Measured by Neuropsychiatric Inventory
Measured: from baseline to Week 12 and Week 24
Change in brain function
Measured by FDG-PET
Measured: from baseline to Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Duk Lyul Na, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940952
- Sponsor's protocol ID
- 2012-03-065
- Other IDs
- 2012-03-065
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Zydena (Udenafil) on Cognitive Function of Alzheimer's Disease Patients: A Randomized, Double Blind, Placebo-controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT01940952
- Acronym / sponsor ID
- 2012-03-065
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zydena 50mg | Active comparator | Drug: Zydena (Udenafil) 50mg + Donepezil 5mg or 10mgZydena (Udenafil) 50mg + Donepezil 5mg or 10mg |
| Placebo | Placebo comparator | Drug: Placebo + Donepezil 5mg or 10mgPlacebo + Donepezil 5mg or 10mg |
| Zydena 100mg | Active comparator | Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mgZydena (Udenafil) 100mg + Donepezil 5mg or 10mg |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zydena (Udenafil) 50mg + Donepezil 5mg or 10mgAlso: Zydena 50mg | Drug | Zydena 50mg |
| Placebo + Donepezil 5mg or 10mgAlso: Placebo | Drug | Placebo |
| Zydena (Udenafil) 100mg + Donepezil 5mg or 10mgAlso: Zydena 100mg | Drug | Zydena 100mg |
Primary outcome
Change in cognitive function
Time frame: from baseline to Week 12 and Week 24 after the administration of the medication
measured by ADAS-cog
3 secondary outcomes
Change in cognitive function
Time frame: from baseline to Week 12 and Week 24
Change in behavioral symptoms
Time frame: from baseline to Week 12 and Week 24
Change in brain function
Time frame: from baseline to Week 12 and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg and Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg in people with Alzheimer's Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enda Go, Clinical Research Coordinator (82-2-3410-2868, ed.ko@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: from baseline to Week 12 and Week 24 after the administration of the medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.