JPRN-jRCT1080222744未知4 期
A post-marketing clinical study of Aricept in patients with dementia with Lewy bodies (DLB)
试验速览
- 阶段
- 4 期
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Outpatient (ambulatory visit from residing nursing facility is accepted)
- •(2) Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to the study institution
- •(3) Patients who can visit study institution as required following with investigator's instructions
- •(4) Patients who can undergo examinations required for this study (use of glasses, hearing aid, etc. are acceptable)
- •(5) Patients who voluntarily submit written informed consent (i.e., consent from patients as much as possible and consent from legal guardians is mandatory)
- •Items to be confirmed at screening test
- •(6) Clinical Dementia Rating (CDR) score is >= 0.5
- •(7) Mini-Mental State Examination (MMSE) score is >= 10 and =< 26
- •(8) Patients diagnosed with probable DLB according to the diagnostic criteria for DLB (Revised version: The 3rd International Workshop version)
- •- Central feature -
- •Dementia defined as progressive cognitive decline of sufficient magnitude to interfere with normal social or occupational function.
- •- Core features -
- •(two core features are sufficient for a diagnosis of probable DLB)
- •1) Fluctuating cognition with pronounced variations in attention and alertness
- •2) Recurrent visual hallucinations that are well formed and detailed
- •3) Spontaneous features of parkinsonism
- •- Suggestive features -
- •(If one or more of these is present in the presence of one or more core features, a diagnosis of probable DLB can be made.)
- •1) REM sleep behavior disorder
- •2) Severe neuroleptic sensitivity
- •3) Low dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET imaging
- •(9) Patients who meet prohibition / restriction of using prohibited and restricted concomitant medications before the start of the observation period
- •Items to be confirmed at immediately before treatment period (Week 0)
- •(10) MMSE score is >= 10 and =< 26
- •(11) NPI-2 (hallucination, fluctuation in cognitive function) is >= 2
排除标准
- •Items to be confirmed before the start of observation period
- •(1) Patients diagnosed with Parkinson's disease with dementia (PDD) (being diagnosed with Parkinson's disease 1 year or more before the onset of dementia)
- •(2) Patients who have received anti-dementia drug therapy (donepezil hydrochloride, rivastigmine, galantamine hydrobromide or memantine hydrochloride) within 12 weeks before the start of the observation period
- •(3) Patients suspected to have a complication of vascular dementia confirmed by MRI or CT test within 1 year before the start of the observation period (localized lesion or multiple infarction in the brain which is a possible cause of dementia) (should be performed and checked during the observation period if not tested within 1 year before the start of the observation period)
- •(4) Patients suspected to have a complication of vascular dementia fromneurological findings
- •(5) Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
- •(6) Patients with severe complication(s) of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety (severe disease is defined referring to Grade 3 of CTCAE (Common Terminology Criteria for Adverse Events) v3.0 Japanese Translation JCOG/JSCO Version-March 8, 2007
- •(7) Patients with a complication or history of severe gastrointestinal ulcer
- •(8) Patients with a complication or history of severe bronchial asthma or obstructive pulmonary disease
- •(9) Patients with a complication of malignant tumor
- •(10) Patients with a complication or history of drug or alcohol abuse within recent 5 years
- •(11) Patients with hypersensitivity to ingredients of donepezil hydrochloride product or to piperidine derivatives
- •(12) Patients planning to use prohibited concomitant medication(s) or to change dosing regimen of restricted concomitant medication(s) during this study
- •(13) Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion
- •(14) Patients who have participated in another clinical study within 12 weeks before the start of the observation period
- •(15) Patients with severe extrapyramidal disorders (Hoehn & Yahr staging score is >= IV)
- •(16) Patients whose systolic blood pressure is < 90 mmHg or pulse rate is < 50 beats/minute at screening test
- •(17) Patients with a complication of sinus failure syndrome, abnormal conduction in the atrial and atrioventricular junction (AV block, >= II ventricular block, etc.), or QT prolongation (QTc >= 450 msec is repeatedly observed)
- •Items to be confirmed before enrollment of treatment period
- •(18) Patients with abnormal laboratory parameters such as abnormal electrolytes, folic acid deficiency, vitamin B12 deficiency, thyroid dysfunction, positive for serologic test for syphilis (STS) which may cause dementia
- •(19) Patients suspected to have a complication of severe disease detected by blood or urine test and not likely to ensure the safety
- •(20) Patients suspected to be pregnant
- •(21) Patients whose systolic blood pressure is < 90 mmHg or pulse rate is < 50 beats/minute immediately before treatment period (Week 0)
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