A post-marketing clinical study of Aricept in patients with dementia with Lewy bodies (DLB)

Phase 4

• Conditions: Dementia with Lewy bodies (DLB)

• Registration Number: JPRN-jRCT1080222744
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 140

Inclusion Criteria

(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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified