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NCT Number: NCT01278407

A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

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

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Key information

Conditions

Dementia With Lewy Bodies (DLB) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anjo-shi, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil 5 mg

Drug

Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg

Other names: E2020

Donepezil 10 mg

Drug

Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg

Other names: E2020

Donepezil matched placebo

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2011
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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