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

Alzheimer's Disease Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02097056
• Other study ID #: ART-M082-401
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 24, 2014
• Last updated: December 4, 2015
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Donepezil HCL
Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Donepezil HCl 23 mg once daily	Safety will be evaluated by all adverse events, serious adverse events, discontinuation from the treatment, prior and concomitant medication, clinical laboratory determinations (biochemistry, blood, urine test), vital signs, weight, ECG, and physical examination.	Baseline up to Week 24	Yes
Secondary	Efficacy of Donepezil HCl 23 mg once daily	MMSE (Mini-Mental State Examination) and NPI-Q (Brief questionnaire form of the Neuropsychiatric Inventory) score will be used to evaluate efficacy. Mean change will be analyzed by paired t-test or Wilcoxon's signed rank test.	Baseline, Week 12, and Week 24 (Final visit)	No