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Trial record 40 of 331 for:    DONEPEZIL

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).

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ClinicalTrials.gov Identifier: NCT02448784
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief 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.

Condition or disease Intervention/treatment
Dementia With Lewy Body Disease Drug: Donepezil Hydrochloride

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Study Type : Observational
Actual Enrollment : 591 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : April 20, 2015
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with DLB
Participants with DLB who will receive donepezil hydrochloride per approved label.
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.
Other Name: Aricept




Primary Outcome Measures :
  1. Mean Mini-Mental State Examination (MMSE) score [ Time Frame: At Week 12 ]
  2. Mean Mini-Mental State Examination (MMSE) score [ Time Frame: At Week 24 ]
  3. Mean Mini-Mental State Examination (MMSE) score [ Time Frame: At Week 52 ]
  4. Mean Revised Hasegawa's Dementia Scale (HDS-R) score [ Time Frame: At Week 12 ]
  5. Mean Revised Hasegawa's Dementia Scale (HDS-R) score [ Time Frame: At Week 24 ]
  6. Mean Revised Hasegawa's Dementia Scale (HDS-R) score [ Time Frame: At Week 52 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) /adverse drug reactions (ADRs) [ Time Frame: From Week 0 to Week 52 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448784


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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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.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02448784     History of Changes
Other Study ID Numbers: ART09T
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: January 2017
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Donepezil Hydrochloride
ARICEPT
Dementia
Lewy bodies
Dementia with Lewy bodies
Post-marketing surveillance
Additional relevant MeSH terms:
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Donepezil
Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents