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Completed

NCT Number: NCT02448784

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).

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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Key information

Conditions

Dementia With Lewy Body Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Naive participants diagnosed as DLB

Exclusion criteria

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

Treatment and study plan

Donepezil Hydrochloride

Drug

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

Primary outcomes

  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 outcomes

  1. Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)

    Time frame: From Week 0 to Week 52

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 19, 2015
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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