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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
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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Brief Summary:
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies (DLB) Drug: Donepezil 5 mg Drug: Donepezil 10 mg Drug: Donepezil matched placebo Phase 3

Detailed Description:
This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo - Confirmatory Phase
Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
 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.
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
  2. 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
  3. Clinical Dementia Rating (CDR) score ≥ 0.5
  4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

  1. Patients diagnosed with Parkinson's disease with dementia (PDD)
  2. Patients who received anti-dementia drug therapy at the same institution
  3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
  4. 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
  5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
  6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Masaki Nakagawa Neuroscience Clinical Development Section. JAC PCU
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
DLB
Dementia with Lewy bodies
Lewy Body Disease
Dementia
 E2020
Donepezil
Aricept
Additional relevant MeSH terms:
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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