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

• 1 other identifier: ART09T
• Study Type: observational
• Target: 591
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia With Lewy Body Disease

Keywords

Donepezil Hydrochloride; ARICEPT; Dementia; Lewy bodies; Dementia with Lewy bodies; Post-marketing surveillance

Outcome Measures

Primary Outcomes (6)

• 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 (1)

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

  From Week 0 to Week 52

Study Arms (1)

Participants with DLB

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

Drug: Donepezil Hydrochloride

Interventions

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.

Also known as: Aricept

Participants with DLB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)

You may qualify if:

• \. Naive participants diagnosed as DLB

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Dementia; Lewy Body Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• 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.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 19, 2015
• Study Start: April 20, 2015
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: July 11, 2018

Record last verified: 2017-01

Locations

JP (1)