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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).

NCT02448784 — Completed, 591 participants, Eisai Co., Ltd.

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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.

RegistryNCT02448784
StatusCompleted
Study typeObservational
Enrollment591 (Actual)
SponsorEisai Co., Ltd. (Industry)
ConditionsDementia With Lewy Body Disease
InterventionsDonepezil Hydrochloride (Drug)
Datesstart 2015-04-20, primary completion 2017-03-30, completion 2017-03-30, first posted 2015-05-19, last updated 2018-07-11
Locations1 site in Japan

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Participants with DLBDrug: Donepezil HydrochlorideParticipants with DLB who will receive donepezil hydrochloride per approved label.
  • Donepezil Hydrochloride (Drug), also known as Aricept: 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.

+Outcome measures

Primary outcomes

  • Mean Mini-Mental State Examination (MMSE) score [At Week 12]
  • Mean Mini-Mental State Examination (MMSE) score [At Week 24]
  • Mean Mini-Mental State Examination (MMSE) score [At Week 52]
  • Mean Revised Hasegawa's Dementia Scale (HDS-R) score [At Week 12]
  • Mean Revised Hasegawa's Dementia Scale (HDS-R) score [At Week 24]
  • Mean Revised Hasegawa's Dementia Scale (HDS-R) score [At Week 52]

Secondary outcomes

  • Number of participants with adverse events (AEs) /adverse drug reactions (ADRs) [From Week 0 to Week 52]

+Eligibility

Sex: All

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 (1)

FacilityCityCountryStatus
TokyoJapan

+Investigators

  • 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.

My Notes