- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197740
A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease
The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch in patients with mild to moderate Alzheimer's disease.
The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301 (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks of treatment in patients with mild to moderate Alzheimer's disease in terms of improvement in cognitive function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) and in terms of global assessment as assessed by Clinician's Interview Based Impression of Change plus Caregiver Input (CIBIC-plus).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- 46 Sites including Konkuk University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age of ≥50 to ≤85 as of the date of informed consent
- Clinical diagnosis of probable Alzheimer's disease according to Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) and National Institute of Neurological and Communicative Disorders and Strokes; Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA)
- Mini Mental Status Examination (MMSE) score ≥10 to ≤26 at screening
- Global Clinical Dementia Rating (CDR) score 0.5, 1 or 2 at screening
- Capable of performing procedures for cognitive and other tests
Subject who meets any of the following as of the date of informed consent
- No past treatment with donepezil (naïve patient)
- Ongoing treatment with donepezil 10mg/day for the past 3 months
- Ongoing treatment with donepezil 5mg/day for the past 3 months
- The subject or his/her representative must voluntarily decide to participate in the study and provide written informed consent.
- The subject must have a reliable caregiver who regularly contacts the subject and is available to accompany the subject for on-site visits. (Note: A caregiver is defined as someone who has regular contact with the subject [i.e., an average of approximately 10 or more hours per week], must be able to oversee subject's compliance with the study treatment and to report on the patient's status and must be able to accompany the subject to all study visits.)
Exclusion Criteria:
- Possible, probable, or definite vascular dementia according to National Institute of Neurological Disorders and Stroke/Association Internationale pur la Recherche et I'Enseignement en Neurosciences (NINDS-AIREN)
- History and/or evidence (computed tomography [CT] or magnetic resonance imaging [MRI] findings obtained within the past 12 months or at screening) of other central nervous system (CNS) disorders (cerebrovascular disease, structural or developmental anomaly, epilepsy, or communicable, degenerative, or infectious/demyelinating CNS conditions) as a cause of dementia Note: >3 lacunar infarcts over 10 mm each, or severe white matter disease equaling a rating of 3 on the age-related white matter changes (ARWMC scale) should be excluded in the study.
- Illiteracy
- Treatment with other anti-dementia drugs (galantamine, memantine, rivastigmine, tacrine), except donepezil, within the past 3 months from the date of informed consent
Treatment with any of the following drugs within the past 2 weeks from the date of informed consent
- CNS stimulants: methylphenidate, modafinil, pemoline, atomoxetine
- Typical antipsychotics: bromperidol, chlorpromazine, haloperidol
- Anticholinergics: atropine, glycopyrrolate, scopolamine, homatropine, ipratropium (short term [within 3 days] use of anticholinergics for the purpose of antispasmodic action on the digestive system is permitted.)
Abnormal blood test findings as follows at the screening test:
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥2.5 x upper limit of normal
- A serum creatinine level of ≥1.5 × ULN for the reference laboratory, or a calculated creatinine clearance by the Cockcroft-Gault equation of ≤50mL/min
Clinically significant abnormal vitamin B12, syphilis serology, or thyroid stimulating hormone (TSH) test findings considered to contribute to the severity of dementia or to be attributable to dementia
Note:
- Clinically significant untreated B12 should be excluded in the study. Subjects are eligible if B12 deficiency is stable after the treatment.
- If the subject has tested False positive for syphilis test, based on the investigator's judgment, further test can be performed to get the final result.
- TSH >10mIU/L should be excluded in the study.
- Diagnosis of serious mental disease based on DSM-5 criteria, including depressive disorder,, schizophrenia, alcoholism, drug dependency, etc.
- Parkinson's disease or parkinsonian syndrome
- Clinically significant electrocardiogram (ECG) abnormalities at screening (heart rate <50 beats/min, atrial and ventricular conduction disorders such as 2nd degree atrioventricular block, QTc interval >480ms)
- History of unstable angina pectoris, myocardial infarction, transient ischemic attack, or coronary intervention including coronary bypass within the past 6 months from the date of informed consent
- History of severe traumatic head injury with loss of consciousness within the past 6 months from the date of informed consent
- Asthma or obstructive pulmonary disease requiring medication
- Gastrointestinal disorders that may affect the absorption, distribution, and metabolism of the study drug (e.g., inflammatory bowel disease, gastric or duodenal ulcer, hepatic disease)
- Uncontrolled diabetes mellitus (defined as HbA1c>9.0%)
- Administration of other investigational products within 3 months prior to treatment with the investigational product (Day 0)
- Hypersensitivity reactions to donepezil HCl, piperidine derivatives, or any of the components of the study drug
Pregnant or lactating woman or woman of childbearing potential who does not agree to use an effective method of contraception.
: Recommended effective methods of birth control include diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, and vasectomized partners. The subject/investigator can discuss any other best method that suits the subject.
- Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Human immunodeficiency virus (HIV) positive or Acquired Immune Deficiency Syndrome (AIDs)
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured, and cervical carcinoma in situ). Cancer survivors not on maintenance therapy that had no malignant disease history within the past 5 years could be recruited.
- Individual considered by the investigator to be ineligible for study participation for other reasons, including having a condition that may affect the assessment of study results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: aricept Tab 5mg
|
Comparator
|
Experimental: donepezil patch 25cm2
|
Treatment
|
Active Comparator: aricept Tab 10mg
|
Comparator
|
Experimental: donepezil patch 50cm2
|
Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADAS-cog
Time Frame: week 24
|
Change at Week 24 of treatment with the study drug from baseline (0d) in ADAS-cog scores
|
week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CIBIC-plus
Time Frame: week 24
|
CIBIC-plus score at the end of treatment (Week 24)
|
week 24
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- IPI-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on aricept Tab
-
Chong Kun Dang PharmaceuticalCompletedCentral Nervous System DiseasesKorea, Republic of
-
Dong-A ST Co., Ltd.CompletedAcute Gastritis | Chronic GastritisKorea, Republic of
-
Chong Kun Dang PharmaceuticalUnknownCardiovascular DiseaseKorea, Republic of
-
Chong Kun Dang PharmaceuticalUnknownCardiovascular DiseaseKorea, Republic of
-
Chong Kun Dang PharmaceuticalUnknown
-
Dong-A ST Co., Ltd.Not yet recruiting
-
Chong Kun Dang PharmaceuticalCompletedChronic Hepatitis bKorea, Republic of
-
Dong-A ST Co., Ltd.CompletedHepatitis BKorea, Republic of
-
Dong-A ST Co., Ltd.Completed
-
Chong Kun Dang PharmaceuticalUnknownChronic Hepatitis bKorea, Republic of