Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

Sponsors

Lead sponsor: Eisai Co., Ltd.

Source Eisai Inc.
Brief Summary

The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).

Overall Status Completed
Start Date November 2007
Completion Date February 2010
Primary Completion Date February 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) Baseline and every 4 weeks up to 12 weeks
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) Baseline and every 4 weeks up to 12 weeks
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) Baseline and week 12
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) Baseline and Week 12
Enrollment 167
Condition
Intervention

Intervention type: Drug

Intervention name: 3 mg Donepezil hydrochloride

Description: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Arm group label: 3 mg Donepezil hydrochloride

Intervention type: Drug

Intervention name: 5 mg Donepezil hydrochloride

Description: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

Arm group label: 5 mg Donepezil hydrochloride

Intervention type: Drug

Intervention name: 10 mg Donepezil hydrochloride

Description: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).

Arm group label: 10 mg Donepezil hydrochloride

Intervention type: Drug

Intervention name: Placebo

Description: Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Arm group label: Placebo

Eligibility

Criteria:

Inclusion criteria:

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Exclusion criteria:

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)

Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Masaki Nakagawa Study Director Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.
Location
facility
| Nagoya, Aichi, Japan
| Obu, Aichi, Japan
| Toyokawa, Aichi, Japan
| Kurume, Fukuoka, Japan
| Omuta, Fukuoka, Japan
| Maebashi, Gunma, Japan
| Miyoshi, Hiroshima, Japan
| Otake, Hiroshima, Japan
| Himeji, Hyogo, Japan
| Kobe, Hyogo, Japan
| Tsukuba, Ibaraki, Japan
| Kahoku, Ishikawa, Japan
| Morioka, Iwate, Japan
| Yokohama, Kanagawa, Japan
| Nankoku, Kochi, Japan
| Koshi, Kumamoto, Japan
| Joyo, Kyoto, Japan
| Sendai, Miyagi, Japan
| Komoro, Nagano, Japan
| Kashihara, Nara, Japan
| Joetsu, Niigata, Japan
| Sanjo, Niigata, Japan
| Yufu, Oita, Japan
| Sakai, Osaka, Japan
| Suita, Osaka, Japan
| Izumo, Shimane, Japan
| Bunkyo-ku, Tokyo, Japan
| Kodaira, Tokyo, Japan
| Koto-ku, Tokyo, Japan
| Ota-ku, Tokyo, Japan
| Setagaya-ku, Tokyo, Japan
| Shinjuku-ku, Tokyo, Japan
| Ube, Yamaguchi, Japan
| Akita, Japan
| Chiba, Japan
| Fukui, Japan
| Fukuoka, Japan
| Kochi, Japan
| Kumamoto, Japan
| Kyoto, Japan
| Osaka, Japan
| Saitama, Japan
| Shizuoka, Japan
Location Countries

Japan

Verification Date

March 2013

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: 3 mg Donepezil hydrochloride

Arm group type: Experimental

Arm group label: 5 mg Donepezil hydrochloride

Arm group type: Experimental

Arm group label: 10 mg Donepezil hydrochloride

Arm group type: Experimental

Arm group label: Placebo

Arm group type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov