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Post-marketing surveillance of donepezil hydrochloride "Dementia with Lewy bodies/long-term administration"

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).

Status
Unknown
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080222854
Enrollment
500
Registered
2015-05-21
Start date
2015-05-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia with Lewy bodies

Interventions

investigational material(s) Generic name etc : Aricept INN of investigational material : Donepezil Hydrochloride Therapeutic category code : 119 Other agents affecting central nervous system Dosage an

Sponsors

Eisai Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ARICEPT-naive patients diagnosed as Dementia with Lewy bodies

Exclusion criteria

Exclusion criteria: 1)Patients with a history of donepezil hydrochloride product administration in the past. 2)Patients who have already been registered in this surveillance. 3)Patients with a history of hypersensitivity to any ingredients of ARICEPT or piperidine derivatives.

Design outcomes

Primary

MeasureTime frame
Cognitive function MMSE or HDS-R—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026