NCT01940952

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

1.9 years

First QC Date

September 9, 2013

Last Update Submit

September 9, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive function

    measured by ADAS-cog

    from baseline to Week 12 and Week 24 after the administration of the medication

Secondary Outcomes (3)

  • Change in cognitive function

    from baseline to Week 12 and Week 24

  • Change in behavioral symptoms

    from baseline to Week 12 and Week 24

  • Change in brain function

    from baseline to Week 12 and Week 24

Study Arms (3)

Zydena 50mg

ACTIVE COMPARATOR

Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg

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

Placebo

PLACEBO COMPARATOR

Placebo + Donepezil 5mg or 10mg

Drug: Placebo + Donepezil 5mg or 10mg

Zydena 100mg

ACTIVE COMPARATOR

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

Drug: Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg

Interventions

Zydena (Udenafil) 50mg + Donepezil 5mg or 10mgDRUG
Also known as: Zydena 50mg
Zydena 50mg
Placebo + Donepezil 5mg or 10mgDRUG
Also known as: Placebo
Placebo
Zydena (Udenafil) 100mg + Donepezil 5mg or 10mgDRUG
Also known as: Zydena 100mg
Zydena 100mg

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samguns Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

udenafilDonepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Enda Go, Clinical Research Coordinator

CONTACT

82-2-3410-2868ed.ko@samsung.com

Duk L. Na, MD. PhD

CONTACT

82-2-3410-3599dukna@naver.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

KR(1)