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

NCT ID: NCT01278407

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-04-30

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.

Conditions

Dementia With Lewy Bodies (DLB)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo - Confirmatory Phase

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

Group Type: PLACEBO_COMPARATOR

Donepezil matched placebo

Intervention Type: DRUG

Donepezil 5 mg - Confirmatory Phase

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.

Group Type: EXPERIMENTAL

Donepezil 5 mg

Intervention Type: DRUG

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

Donepezil 10 mg - Confirmatory Phase

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.

Group Type: EXPERIMENTAL

Donepezil 10 mg

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

Donepezil 10 mg

Intervention Type: DRUG

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

Donepezil (5 +10 mg) - Extension Phase

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.

Group Type: EXPERIMENTAL

Donepezil 10 mg

Intervention Type: DRUG

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

Interventions

Donepezil 5 mg

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

Intervention Type: DRUG

Donepezil 10 mg

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

Intervention Type: DRUG

Donepezil matched placebo

Intervention Type: DRUG

Other Intervention Names

E2020; E2020

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masaki Nakagawa

Role: STUDY_DIRECTOR

Neuroscience Clinical Development Section. JAC PCU

Locations

Anjo-shi, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Toyokawa-shi, Aichi-ken, Japan

Chiba, Chiba, Japan

Fukui-shi, Fukui, Japan

Yoshida-gun, Fukui, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Omuta-shi, Fukuoka, Japan

Gifu, Gifu, Japan

Mizunami-shi, Gifu, Japan

Fujioka-shi, Gunma, Japan

Maebashi, Gunma, Japan

Kure-shi, Hiroshima, Japan

Miyoshi-shi, Hiroshima, Japan

Otake-shi, Hiroshima, Japan

Obihiro-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Himeji-shi, Hyōgo, Japan

Kobe, Hyōgo, Japan

Yabu-shi, Hyōgo, Japan

Bando-shi, Ibaraki, Japan

Hitachi-shi, Ibaraki, Japan

Kahoku, Ishikawa-ken, Japan

Morioka, Iwate, Japan

Fujisawa-shi, Kanagawa, Japan

Kochi, Kochi, Japan

Koshi-shi, Kumamoto, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Uji-shi, Kyoto, Japan

Sendai, 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 Prefecture, Japan

Osaka, 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, Shizuoka, Japan

Shizuoka, Shizuoka, Japan

Koto-ku, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Suginami-ku, Tokyo, Japan

Countries

Japan

References

Mori E, Ikeda M, Nagai R, Matsuo K, Nakagawa M, Kosaka K. Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):5. doi: 10.1186/s13195-014-0081-2. eCollection 2015.

Reference Type: DERIVED

PMID: 25713600 (View on PubMed)

Ikeda M, Mori E, Matsuo K, Nakagawa M, Kosaka K. Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):4. doi: 10.1186/s13195-014-0083-0. eCollection 2015.

Reference Type: DERIVED

PMID: 25713599 (View on PubMed)

Other Identifiers

E2020-J081-341

Identifier Type: -

Identifier Source: org_study_id