Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease

NCT ID: NCT02097056

Last Updated: 2016-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-05-31

Brief Summary

This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease.

Detailed Description

This study consisted of pre-treatment and treatment phase. Pre-treatment phase was approximately 4 weeks including the screening and baseline process. In treatment phase, about 190 subjects received Donepezil HCl 23 mg once daily for 24 weeks.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

donepezil HCl 23 mg

Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Group Type: EXPERIMENTAL

Donepezil HCL

Intervention Type: DRUG

Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Interventions

Donepezil HCL

Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 45 to 90 years

2. Patients have eligible conditions of dementia diagnosis listed in DSM-IV

3. Diagnosed as a probable Alzheimer's Disease patient according to NINCDS-ADRDA criteria

4. At the timing of screening, MMSE less than or equal to 20 AND CDR greater than or equal to 2 OR GDS greater than or equal to 4

5. Patients, who have been taking stable donepezil 10 mg for 3 months or longer before the start of the study (screening visit), are evaluated as eligible to take donepezil 23 mg by investigator

6. Patients who have not received any other medications for AD such as AChE inhibitors at least for 3 months prior to the screening visit excluding donepezil hydrochloride (However, concomitant use of memantine is allowed if taken at stable dose that are less than or equal to the approved dose range for at least 3 months prior to screening)

7. Medicines for cerebral activation such as Gingko Biloba is allowed to be taken if the patient has received it as stable dose for 3 months prior to the screening visit

Exclusion Criteria

1. Patients who have been participated in any other clinical trial 3 months prior to the screening visit

2. Patients who are having any severe psychiatric disorder or schizophrenia

3. Patients who are having a neurological disorder other than AD which affect the subject's cognition or ability to assess the cognition

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Korea Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ansan, Gyeonggi-do, South Korea

Buchoen, Gyeonggi-do, South Korea

Seongnam-si, Gyeonggi-do, South Korea

Jinju, Gyeongsangnam-do, South Korea

Iksan, Jeollabuk-do, South Korea

Hwasun, Jeollanam-do, South Korea

Busan, Korea, Republic of, South Korea

Daegu, Korea, Republic of, South Korea

Daejeon, Korea, Republic of, South Korea

Incheon, Korea, Republic of, South Korea

Jeju City, Korea, Republic of, South Korea

Seoul, Korea, Republic of, South Korea

Chungju, North Chungcheong, South Korea

Countries

South Korea

Other Identifiers

ART-M082-401

Identifier Type: -

Identifier Source: org_study_id