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A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

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ClinicalTrials.gov Identifier: NCT00598650
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dementia With Lewy Bodies (DLB)
Intervention Drug: E2020
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title E2020
Hide Arm/Group Description Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Period Title: Overall Study
Started 108
Completed 81 [1]
Not Completed 27
Reason Not Completed
Withdrawal by Subject             3
Adverse Event             18
No treatment for 3 weeks             1
Not eligible             1
Prohibited Concomitant Medication             2
Physician Decision             2
[1]
5 subjects withdrew for multiple reasons
Arm/Group Title E2020
Hide Arm/Group Description Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Overall Number of Baseline Participants 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
78.9  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
68
  63.0%
Male
40
  37.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 108 participants
49  (9.24)
1.Primary Outcome
Title Change From Baseline in Mini-mental State Examination (MMSE) Total
Hide Description MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.
Time Frame Baseline, Week 52, and Week 52 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.
Arm/Group Title E2020 Placebo/E2020
Hide Arm/Group Description:
Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
Overall Number of Participants Analyzed 104 28
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 20.9  (5.1) 18.6  (4.7)
Week 52 0.3  (3.7) 2  (4.4)
Week 52 LOCF 0.2  (3.5) 1.7  (4.4)
2.Primary Outcome
Title Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
Hide Description NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.
Time Frame Baseline, Week 52, and Week 52 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set
Arm/Group Title E2020 Placebo/E2020
Hide Arm/Group Description:
Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
Overall Number of Participants Analyzed 104 28
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 13.1  (16.8) 17.8  (8.2)
Week 52 -1.9  (9.8) -4.1  (10.1)
Week 52 LOCF -0.7  (11.1) -4.3  (9.7)
Time Frame Up to 52 weeks
Adverse Event Reporting Description Other adverse events are listed at a frequency of 5% or greater
 
Arm/Group Title E2020
Hide Arm/Group Description Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
All-Cause Mortality
E2020
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E2020
Affected / at Risk (%)
Total   8/108 (7.41%) 
Cardiac disorders   
Myocardial infarction * 1  1/108 (0.93%) 
Gastrointestinal disorders   
Gastrointestinal mucosal exfoliation * 1  1/108 (0.93%) 
Pancreatitis acute * 1  1/108 (0.93%) 
Hepatobiliary disorders   
Hepatic function abnormal * 1  1/108 (0.93%) 
Infections and infestations   
Pneumonia * 1  3/108 (2.78%) 
Pseudomembranous colitis * 1  1/108 (0.93%) 
Injury, poisoning and procedural complications   
Compression fracture * 1  3/108 (2.78%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/108 (1.85%) 
Decreased appetite * 1  1/108 (0.93%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/108 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cervix carcinoma * 1  1/108 (0.93%) 
Bile duct cancer * 1  1/108 (0.93%) 
Prostate cancer * 1  1/108 (0.93%) 
Bladder cancer * 1  1/108 (0.93%) 
Nervous system disorders   
Dizziness * 1  1/108 (0.93%) 
Cerebellar infarction * 1  1/108 (0.93%) 
Radial nerve palsy * 1  1/108 (0.93%) 
Subarachnoid haemorrhage * 1  1/108 (0.93%) 
Psychiatric disorders   
Psychiatric symptom * 1  1/108 (0.93%) 
Poriomania * 1  1/108 (0.93%) 
Renal and urinary disorders   
Renal failure acute * 1  1/108 (0.93%) 
Respiratory, thoracic and mediastinal disorders   
Asphyxia * 1  1/108 (0.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E2020
Affected / at Risk (%)
Total   53/108 (49.07%) 
Gastrointestinal disorders   
Diarrhoea * 1  10/108 (9.26%) 
Constipation * 1  8/108 (7.41%) 
Infections and infestations   
Nasopharyngitis * 1  11/108 (10.19%) 
Injury, poisoning and procedural complications   
Contusion * 1  12/108 (11.11%) 
Fall * 1  11/108 (10.19%) 
Compression fracture * 1  6/108 (5.56%) 
Investigations   
Blood creatine phosphokinase increased * 1  12/108 (11.11%) 
Blood pressure increased * 1  11/108 (10.19%) 
Blood urine present * 1  7/108 (6.48%) 
Protein urine present * 1  7/108 (6.48%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  6/108 (5.56%) 
Nervous system disorders   
Parkinsonism * 1  8/108 (7.41%) 
Psychiatric disorders   
Insomnia * 1  6/108 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Masaki Nakagawa
Organization: Eisai Co., Ltd.
Phone: +81-3-3817-5245 ext 5245
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00598650     History of Changes
Other Study ID Numbers: E2020-J081-432
First Submitted: January 10, 2008
First Posted: January 22, 2008
Results First Submitted: August 8, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014