A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

Sponsors

Lead Sponsor: Eisai Co., Ltd.

Source Eisai Inc.
Brief Summary

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Detailed Description

This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.

Overall Status Completed
Start Date February 2011
Completion Date April 2013
Primary Completion Date March 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Mini-Mental State Examination (MMSE) Score Week 12 for Confirmatory Phase
Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score Week 12 for Confirmatory Phase
Enrollment 142
Condition
Intervention

Intervention Type: Drug

Intervention Name: Donepezil 5 mg

Description: Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg

Arm Group Label: Donepezil 5 mg - Confirmatory Phase

Other Name: E2020

Intervention Type: Drug

Intervention Name: Donepezil 10 mg

Description: Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg

Other Name: E2020

Intervention Type: Drug

Intervention Name: Donepezil matched placebo

Arm Group Label: Placebo - Confirmatory Phase

Eligibility

Criteria:

Inclusion Criteria

1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB

2. Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution

3. Clinical Dementia Rating (CDR) score ≥ 0.5

4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)

2. Patients who received anti-dementia drug therapy at the same institution

3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening

4. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency

5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)

6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening

Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Masaki Nakagawa Study Director Neuroscience Clinical Development Section. JAC PCU
Location
Facility:
| Anjo-shi, Aichi, Japan
| Nagoya-shi, Aichi, Japan
| Toyokawa-shi, Aichi, Japan
| Chiba-shi, Chiba, Japan
| Fukui-shi, Fukui, Japan
| Yoshida-gun, Fukui, Japan
| Fukuoka-shi, Fukuoka, Japan
| Kitakyushu-shi, Fukuoka, Japan
| Omuta-shi, Fukuoka, Japan
| Gifu-shi, Gifu, Japan
| Mizunami-shi, Gifu, Japan
| Fujioka-shi, Gunma, Japan
| Maebashi-shi, Gunma, Japan
| Kure-shi, Hiroshima, Japan
| Miyoshi-shi, Hiroshima, Japan
| Otake-shi, Hiroshima, Japan
| Obihiro-shi, Hokkaido, Japan
| Sapporo-shi, Hokkaido, Japan
| Himeji-shi, Hyogo, Japan
| Kobe-shi, Hyogo, Japan
| Yabu-shi, Hyogo, Japan
| Bando-shi, Ibaraki, Japan
| Hitachi-shi, Ibaraki, Japan
| Kahoku-shi, Ishikawa, Japan
| Morioka-shi, Iwate, Japan
| Fujisawa-shi, Kanagawa, Japan
| Kochi-shi, Kochi, Japan
| Koshi-shi, Kumamoto, Japan
| Kumamoto-shi, Kumamoto, Japan
| Kyoto-shi, Kyoto, Japan
| Uji-shi, Kyoto, Japan
| Sendai-shi, Miyagi, Japan
| Higashimorokata-gun, Miyazaki, Japan
| Ina-shi, Nagano, Japan
| Kitaazumi-gun, Nagano, Japan
| Matsumoto-shi, Nagano, Japan
| Nishisonogi-gun, Nagasaki, Japan
| Nagaoka-shi, Niigata, Japan
| Sanjo-shi, Niigata, Japan
| Tsubame-shi, Niigata, Japan
| Yufu-shi, Oita, Japan
| Osaka-shi, Osaka, Japan
| Sakai-shi, Osaka, Japan
| Sennan-shi, Osaka, Japan
| Suita-shi, Osaka, Japan
| Ageo-shi, Saitama, Japan
| Kasukabe-shi, Saitama, Japan
| Saitama-shi, Saitama, Japan
| Fuji-shi, Shizuoka, Japan
| Hamamatsu-shi, Shizuoka, Japan
| Shizuoka-shi, Shizuoka, Japan
| Koto-ku, Tokyo, Japan
| Ota-ku, Tokyo, Japan
| Setagaya-ku, Tokyo, Japan
| Shinjuku-ku, Tokyo, Japan
| Suginami-ku, Tokyo, Japan
Location Countries

Japan

Verification Date

December 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Placebo - Confirmatory Phase

Type: Placebo Comparator

Description: Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.

Label: Donepezil 5 mg - Confirmatory Phase

Type: Experimental

Description: Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.

Label: Donepezil 10 mg - Confirmatory Phase

Type: Experimental

Description: Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.

Label: Placebo to Donepezil (5 +10 mg) - Extension Phase

Type: Experimental

Description: Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.

Label: Donepezil (5 +10 mg) - Extension Phase

Type: Experimental

Description: Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov