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).

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 30, 2017

Interventions

  • Drug: Donepezil Hydrochloride
    • 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.

Arms, Groups and Cohorts

  • Participants with DLB
    • Participants with DLB who will receive donepezil hydrochloride per approved label.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kazuhiro Omata, Study Director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
    • Syoya Yamakawa, Study Director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

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