Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with DLB | Participants with DLB who will receive donepezil hydrochloride per approved label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) /adverse drug reactions (ADRs) | From Week 0 to Week 52 |
Not provided
Inclusion Criteria:
1. Naive participants diagnosed as DLB
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
Not provided
Not provided
Not provided
Not provided
|
|
| ID | Term |
|---|---|
| D003704 | Dementia |
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided