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

Eisai

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Donepezil HCL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097056

ART-M082-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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171 participants in 1 patient group

donepezil HCl 23 mg

Experimental group

Description:

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

Treatment:

Drug: Donepezil HCL