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

NCT03197740 | Completed Phase 3

• 1 other identifier: IPI-003
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• ADAS-cog

  Change at Week 24 of treatment with the study drug from baseline (0d) in ADAS-cog scores

  week 24

Secondary Outcomes (1)

• CIBIC-plus

  week 24

Study Arms (4)

aricept Tab 5mg

ACTIVE COMPARATOR

Drug: aricept Tab

donepezil patch 25cm2

EXPERIMENTAL

Drug: Donepezil patch

aricept Tab 10mg

ACTIVE COMPARATOR

Drug: aricept Tab

donepezil patch 50cm2

EXPERIMENTAL

Drug: Donepezil patch

Interventions

Donepezil patch DRUG

Treatment

donepezil patch 25cm2; donepezil patch 50cm2

aricept Tab DRUG

Comparator

aricept Tab 10mg; aricept Tab 5mg

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icure Pharmaceutical Inc.: lead

Study Sites (1)

46 Sites including Konkuk University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 23, 2017
• Study Start: October 12, 2017
• Primary Completion: July 3, 2020
• Study Completion: July 20, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

KR (1)