Clinical trial NCT02097056: Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Official title: Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 171
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Summary of Adverse Events (AEs)
timeFrame: Baseline (Day 1) up to Week 24
Secondary outcomes:
measure: Change From Baseline in the Mini-Mental State Examination (MMSE) Score
timeFrame: Baseline, Week 12, and Week 24 (Final visit)
measure: Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores
timeFrame: Baseline, Week 12, and Week 24 (Follow up visit)
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
state: Chungcheongbuk-do
city: Ansan
country: Korea, Republic of
state: Gyeonggi-do
city: Buchoen
country: Korea, Republic of
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
state: Gyeonggi-do
city: Jinju
country: Korea, Republic of
state: Gyeongsangnam-do
city: Iksan
country: Korea, Republic of
state: Jeollabuk-do
city: Hwasun
country: Korea, Republic of
state: Jeollanam-do
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
References: