Trial Outcomes & Findings for A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies (NCT NCT00598650)
NCT ID: NCT00598650
Last Updated: 2014-09-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Baseline, Week 52, and Week 52 LOCF
Results posted on
2014-09-03
Participant Flow
Participant milestones
| Measure |
E2020
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 Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
E2020
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 Study
Withdrawal by Subject
|
3
|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
No treatment for 3 weeks
|
1
|
|
Overall Study
Not eligible
|
1
|
|
Overall Study
Prohibited Concomitant Medication
|
2
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Baseline characteristics by cohort
| Measure |
E2020
n=108 Participants
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.
|
|---|---|
|
Age, Continuous
|
78.9 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Weight
|
49 kg
STANDARD_DEVIATION 9.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52, and Week 52 LOCFPopulation: 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.
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.
Outcome measures
| Measure |
E2020
n=104 Participants
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.
|
Placebo/E2020
n=28 Participants
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).
|
|---|---|---|
|
Change From Baseline in Mini-mental State Examination (MMSE) Total
Baseline
|
20.9 Score on a Scale
Standard Deviation 5.1
|
18.6 Score on a Scale
Standard Deviation 4.7
|
|
Change From Baseline in Mini-mental State Examination (MMSE) Total
Week 52
|
0.3 Score on a Scale
Standard Deviation 3.7
|
2 Score on a Scale
Standard Deviation 4.4
|
|
Change From Baseline in Mini-mental State Examination (MMSE) Total
Week 52 LOCF
|
0.2 Score on a Scale
Standard Deviation 3.5
|
1.7 Score on a Scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Baseline, Week 52, and Week 52 LOCFPopulation: Efficacy Analysis Set
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.
Outcome measures
| Measure |
E2020
n=104 Participants
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.
|
Placebo/E2020
n=28 Participants
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).
|
|---|---|---|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
Baseline
|
13.1 Score on a Scale
Standard Deviation 16.8
|
17.8 Score on a Scale
Standard Deviation 8.2
|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
Week 52
|
-1.9 Score on a Scale
Standard Deviation 9.8
|
-4.1 Score on a Scale
Standard Deviation 10.1
|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
Week 52 LOCF
|
-0.7 Score on a Scale
Standard Deviation 11.1
|
-4.3 Score on a Scale
Standard Deviation 9.7
|
Adverse Events
E2020
Serious events: 8 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E2020
n=108 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Compression fracture
|
2.8%
3/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Psychiatric disorders
Psychiatric symptom
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Psychiatric disorders
Poriomania
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Nervous system disorders
Cerebellar infarction
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Infections and infestations
Pneumonia
|
2.8%
3/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Gastrointestinal disorders
Gastrointestinal mucosal exfoliation
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Nervous system disorders
Radial nerve palsy
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
2/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Renal and urinary disorders
Renal failure acute
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Cardiac disorders
Myocardial infarction
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Infections and infestations
Pseudomembranous colitis
|
0.93%
1/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
Other adverse events
| Measure |
E2020
n=108 participants at risk
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.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.2%
11/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
6/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Psychiatric disorders
Insomnia
|
5.6%
6/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Nervous system disorders
Parkinsonism
|
7.4%
8/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
10/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Gastrointestinal disorders
Constipation
|
7.4%
8/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Investigations
Blood creatine phosphokinase increased
|
11.1%
12/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Investigations
Blood pressure increased
|
10.2%
11/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Investigations
Blood urine present
|
6.5%
7/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Investigations
Protein urine present
|
6.5%
7/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
12/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Injury, poisoning and procedural complications
Fall
|
10.2%
11/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
|
Injury, poisoning and procedural complications
Compression fracture
|
5.6%
6/108 • Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
|
Additional Information
Masaki Nakagawa
Eisai Co., Ltd.
Phone: +81-3-3817-5245
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER