Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).

July 10, 2018 updated by: Eisai Co., Ltd.

Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.

To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

591

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)

Description

Inclusion Criteria:

1. Naive participants diagnosed as DLB

Exclusion Criteria:

  1. Participants with a history of donepezil hydrochloride product administration in the past
  2. Participants who have already been registered in this surveillance
  3. Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with DLB
Participants with DLB who will receive donepezil hydrochloride per approved label.
Initial dose for oral use is 3 mg once daily. The dose is increased to 5 mg after 1-2 weeks. Following at least 4 weeks of dosing at 5 mg, the dose is increased to 10 mg. The dose may be decreased to 5 mg depending on the symptoms of the participant.
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Mini-Mental State Examination (MMSE) score
Time Frame: At Week 12
At Week 12
Mean Mini-Mental State Examination (MMSE) score
Time Frame: At Week 24
At Week 24
Mean Mini-Mental State Examination (MMSE) score
Time Frame: At Week 52
At Week 52
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time Frame: At Week 12
At Week 12
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time Frame: At Week 24
At Week 24
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time Frame: At Week 52
At Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)
Time Frame: From Week 0 to Week 52
From Week 0 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Kazuhiro Omata, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
  • Study Director: Syoya Yamakawa, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2015

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 15, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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