A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
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ClinicalTrials.gov Identifier: NCT01278407 |
Recruitment Status :
Completed
First Posted : January 17, 2011
Results First Posted : November 30, 2015
Last Update Posted : February 2, 2016
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Condition or disease | Intervention/treatment | Phase |
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Dementia With Lewy Bodies (DLB) | Drug: Donepezil 5 mg Drug: Donepezil 10 mg Drug: Donepezil matched placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 142 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo - Confirmatory Phase
Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
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Drug: Donepezil matched placebo |
Experimental: Donepezil 5 mg - Confirmatory Phase
Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
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Drug: Donepezil 5 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
Other Name: E2020 |
Experimental: Donepezil 10 mg - Confirmatory Phase
Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
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Drug: Donepezil 10 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Name: E2020 |
Experimental: Placebo to Donepezil (5 +10 mg) - Extension Phase
Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
|
Drug: Donepezil 10 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Name: E2020 |
Experimental: Donepezil (5 +10 mg) - Extension Phase
Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
|
Drug: Donepezil 10 mg
Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
Other Name: E2020 |
- Change From Baseline in Mini-Mental State Examination (MMSE) Score [ Time Frame: Week 12 for Confirmatory Phase ]The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.
- Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score [ Time Frame: Week 12 for Confirmatory Phase ]The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation [reported as cognitive fluctuation inventory]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
- Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
- Clinical Dementia Rating (CDR) score ≥ 0.5
- Mini-Mental State Examination (MMSE) score of 10 to 26
Exclusion Criteria
- Patients diagnosed with Parkinson's disease with dementia (PDD)
- Patients who received anti-dementia drug therapy at the same institution
- Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
- 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
- Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
- Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278407

Study Director: | Masaki Nakagawa | Neuroscience Clinical Development Section. JAC PCU |
Responsible Party: | Eisai Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01278407 |
Other Study ID Numbers: |
E2020-J081-341 |
First Posted: | January 17, 2011 Key Record Dates |
Results First Posted: | November 30, 2015 |
Last Update Posted: | February 2, 2016 |
Last Verified: | December 2015 |
DLB Dementia with Lewy bodies Lewy Body Disease Dementia |
E2020 Donepezil Aricept |
Dementia Lewy Body Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Neurodegenerative Diseases Parkinsonian Disorders Basal Ganglia Diseases |
Movement Disorders Synucleinopathies Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |