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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).

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dementia With Lewy Body Disease

Intervention: Donepezil Hydrochloride (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Eisai Co., Ltd.

Official(s) and/or principal investigator(s):
Kazuhiro Omata, Study Director, Affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Syoya Yamakawa, Study Director, Affiliation: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

Overall contact:
Customer Joy Department. EJ, Phone: 81-120-161-454

Summary

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.

Clinical Details

Official title: 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.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Mean Mini-Mental State Examination (MMSE) score

Mean Mini-Mental State Examination (MMSE) score

Mean Mini-Mental State Examination (MMSE) score

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Secondary outcome: Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Customer Joy Department. EJ, Phone: 81-120-161-454

Multiple Sites, Tokyo, Japan; Recruiting
Additional Information

Starting date: April 2015
Last updated: May 15, 2015

Page last updated: August 20, 2015

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