NCT02345213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2017

Enrollment Period

2.2 years

First QC Date

January 19, 2015

Last Update Submit

January 7, 2019

Conditions

Dementia, Lewy BodyLewy Body Disease

Keywords

DLBDementia with Lewy bodiesLewy Body DiseaseDementiaE2020DonepezilAricept

Outcome Measures

Primary Outcomes (1)

  • Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)

    CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse".

    Up to 12 weeks

Study Arms (2)

E2020

EXPERIMENTAL

Treatment period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-12 E2020 10 mg. Extension period: Weeks 1-6 E2020 10 mg, After Week 7 up to week 60 E2020 10 mg.

Drug: E2020

Placebo

PLACEBO COMPARATOR

Treatment period: Weeks 1-12 placebo Extension period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, After Week 7 up to week 60 E2020 10 mg.

Drug: Placebo

Interventions

E2020DRUG

E2020 tablets will be orally administered once daily after breakfast

E2020
PlaceboDRUG

Matching placebo tablets will be orally administered once daily after breakfast

Placebo

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
  • Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution
  • Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
  • Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

You may not qualify if:

  • Patients diagnosed with Parkinson's disease with dementia (PDD)
  • Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
  • 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
  • Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
  • Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Saitama, Japan

Location

MeSH Terms

Conditions

Lewy Body DiseaseDementia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Megumi Ohdake

    Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

March 1, 2015

Primary Completion

May 15, 2017

Study Completion

March 26, 2018

Last Updated

January 8, 2019

Record last verified: 2017-12

Locations

JP(1)