Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment donepezil hcl
Phase phase 4
Sponsor Eisai Korea Inc.
Start date February 2014
End date May 2015
Trial size 171 participants
Trial identifier NCT02097056, ART-M082-401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
donepezil hcl
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Primary Outcomes

Measure
Safety of Donepezil HCl 23 mg once daily
time frame: Baseline up to Week 24

Secondary Outcomes

Measure
Efficacy of Donepezil HCl 23 mg once daily
time frame: Baseline, Week 12, and Week 24 (Final visit)

Eligibility Criteria

Male or female participants from 45 years up to 90 years old.

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

Additional Information

Official title Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..