A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

NCT00598650 | Completed Phase 2 Results

• 1 other identifier: E2020-J081-432
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dementia With Lewy Bodies (DLB)

Keywords

Lewy Body Disease; Dementia; Clinical Trial; Phase II; E2020; donepezil hydrochloride

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mini-mental State Examination (MMSE) Total

  MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.

  Baseline, Week 52, and Week 52 LOCF

• Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms

  NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.

  Baseline, Week 52, and Week 52 LOCF

Study Arms (1)

1

EXPERIMENTAL

Drug: E2020

Interventions

E2020 DRUG

Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.

Also known as: Aricept

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
• Patients who have completed Phase II double-blind study (E2020-J081-431).
• Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

You may not qualify if:

• 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, and/or who underwent brain surgery causing unsolved deficiency.
• Patients 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.
• Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
• Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

MeSH Terms

Conditions

Lewy Body Disease; Dementia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Masaki Nakagawa
• Organization: Eisai Co., Ltd.

+81-3-3817-5245

Study Officials

• Itaru Arimoto

  New Product Development, Clinical Research Center, Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 22, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 3, 2014
• Results First Posted: September 3, 2014

Record last verified: 2014-08