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).

Dementia With Lewy Body Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448784
• Other study ID #: ART09T
• Status: Completed
• Start date: April 20, 2015
• Est. completion date: March 30, 2017

Study information

• Verified date: January 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Body Disease
• Lewy Body Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Mini-Mental State Examination (MMSE) score		At Week 12
Primary	Mean Mini-Mental State Examination (MMSE) score		At Week 24
Primary	Mean Mini-Mental State Examination (MMSE) score		At Week 52
Primary	Mean Revised Hasegawa's Dementia Scale (HDS-R) score		At Week 12
Primary	Mean Revised Hasegawa's Dementia Scale (HDS-R) score		At Week 24
Primary	Mean Revised Hasegawa's Dementia Scale (HDS-R) score		At Week 52
Secondary	Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)		From Week 0 to Week 52