Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

NCT ID: NCT01539031

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.

Conditions

Alzheimer's Type Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg group

Group Type: EXPERIMENTAL

E2020

Intervention Type: DRUG

Subjects in the Group-10 mg:

Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg

23 mg group

Group Type: ACTIVE_COMPARATOR

E2020

Intervention Type: DRUG

Subjects in the Group-23 mg:

Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg

Interventions

E2020

Subjects in the Group-10 mg:

Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg

Intervention Type: DRUG

E2020

Subjects in the Group-23 mg:

Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis: diagnostic evidence of probable Alzheimer's disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) 290.00 or 290.10
• Mini Mental State Examination (MMSE) less than or equal to 12 and greater than or equal to1 inclusive, at Screening
• SIB less than or equal to 90 and greater than or equal to10 at both Screening and Baseline
• No evidence of focal disease to account for dementia on any cranial image (magnetic resonance imaging [MRI] or computed tomography [CT]).
• Subject age range: male and female subjects greater than or equal to 50 years of age inclusive
• Outpatients (patients in nursing homes are eligible)
• The subject must have a caregiver who will provide informed consent separately for his/her own participation in the study, who will have regular contact with the subject.
• Stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or equal to 3 months prior to the Screening visit
• Subjects who can swallow hole tablets, as tablets should not be broken or crushed
• Comorbid medical conditions must be clinically stable prior to Screening unless otherwise specified.
• Written informed consent will be obtained from the subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.

Exclusion Criteria

• Subjects with a known history of disorders that affect cognition or the ability to assess cognition but are distinguishable from AD
• Subjects with dementia complicated by other organic disease or AD with delirium
• Known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation
• Patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary)
• Use of any prohibited prior or concomitant medications. Memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to Screening.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naoki Kubota

Role: STUDY_DIRECTOR

Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.

Locations

Anjo, Aichi-ken, Japan

Ōbu, Aichi-ken, Japan

Toyoake, Aichi-ken, Japan

Chikushi, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Fukuoka, Gunma, Japan

Miyoshi, Hiroshima, Japan

Ōtake, Hiroshima, Japan

Amagasaki, Hyōgo, Japan

Himeji, Hyōgo, Japan

Morioka, Iwate, Japan

Numakunai, Iwate, Japan

Kida, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Kawasaki, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Maizuru, Kyoto, Japan

Nagasaki, Kyushu, Japan

Sendai, Miyagi, Japan

Kitamorokata, Miyazaki, Japan

Ina, Nagano, Japan

Nagaoka, Niigata, Japan

Kurashiki, Okayama-ken, Japan

Ibaraki, Osaka, Japan

Ikeda, Osaka, Japan

Sakai, Osaka, Japan

Sennan, Osaka, Japan

Takatsuki, Osaka, Japan

Age, Saitama, Japan

Iruma, Saitama, Japan

Kasukabe, Saitama, Japan

Tokorozawa, Saitama, Japan

Fuji, Shizuoka, Japan

Izunokuni, Shizuoka, Japan

Anan, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Koto, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya City, Tokyo, Japan

Suginami, Tokyo, Japan

Akita, , Japan

Chiba, , Japan

Fukuoka, , Japan

Hiroshima, , Japan

Kagoshima, , Japan

Kochi, , Japan

Kyoto, , Japan

Nara, , Japan

Osaka, , Japan

Saitama, , Japan

Tokushima, , Japan

Countries

Japan

Other Identifiers

E2020-J081-343

Identifier Type: -

Identifier Source: org_study_id