Trial Outcomes & Findings for A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia (NCT NCT01276353)
NCT ID: NCT01276353
Last Updated: 2014-08-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Visit 2 [Day1] and Visit 3 [Day 15]
Results posted on
2014-08-08
Participant Flow
Participant milestones
| Measure |
E2020 SR 23 mg
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
|---|---|---|
|
Double-blind
STARTED
|
22
|
23
|
|
Double-blind
COMPLETED
|
19
|
23
|
|
Double-blind
NOT COMPLETED
|
3
|
0
|
|
Extension
STARTED
|
19
|
23
|
|
Extension
COMPLETED
|
12
|
14
|
|
Extension
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
E2020 SR 23 mg
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
|---|---|---|
|
Double-blind
Adverse Event
|
2
|
0
|
|
Double-blind
Withdrawal by Subject
|
1
|
0
|
|
Extension
Adverse Event
|
2
|
5
|
|
Extension
Withdrawal by Subject
|
1
|
2
|
|
Extension
Withdrawal of study drug 4 days in a row
|
3
|
1
|
|
Extension
Physician Decision
|
1
|
0
|
|
Extension
Prohibited concomitant medications
|
0
|
1
|
Baseline Characteristics
A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
Baseline characteristics by cohort
| Measure |
E2020 SR 23 mg
n=22 Participants
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg
n=23 Participants
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.3 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
73.6 Years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
76.4 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Hachinski Score
|
1.1 Scores on a Scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
0.7 Scores on a Scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
0.9 Scores on a Scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 [Day1] and Visit 3 [Day 15]Population: Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma
Outcome measures
| Measure |
E2020 SR 23 mg
n=22 Participants
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg (EM)
n=23 Participants
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
Visit 2
|
126.503 ng/mL
Standard Deviation 31.27
|
97.006 ng/mL
Standard Deviation 32.934
|
|
Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
Visit 3
|
127.335 ng/mL
Standard Deviation 40.654
|
66.081 ng/mL
Standard Deviation 24
|
SECONDARY outcome
Timeframe: Visit 2 [Day1] and Visit 3 [Day 15]Population: Pharmacokinetic Analysis Set
All subjects were identified as Extensive Metabolizer \[EM\] or Intermediate Metabolizer \[IM\] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i
Outcome measures
| Measure |
E2020 SR 23 mg
n=22 Participants
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg (EM)
n=23 Participants
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
|---|---|---|
|
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Visit 2 EM [IR: n=16, SR: n=17]
|
117.999 ng/mL
Standard Deviation 28.898
|
98.117 ng/mL
Standard Deviation 32.323
|
|
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Visit 2 IM [IR: n=5, SR: n=4]
|
161.363 ng/mL
Standard Deviation 18.761
|
104.294 ng/mL
Standard Deviation 23.962
|
|
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Visit 3 EM [IR: n=16, SR: n=15]
|
116.771 ng/mL
Standard Deviation 31.663
|
63.896 ng/mL
Standard Deviation 20.662
|
|
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Visit 2 IM [IR: n=5, SR: n=3]
|
182.953 ng/mL
Standard Deviation 48.422
|
79.802 ng/mL
Standard Deviation 24.984
|
Adverse Events
E2020 SR 23 mg (Double-blind)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
E2020 10 mg (Double-blind)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
E2020 SR 23 mg (Extension)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
E2020 10 mg (Extension)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E2020 SR 23 mg (Double-blind)
n=22 participants at risk
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
|
E2020 10 mg (Double-blind)
n=23 participants at risk
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
|
E2020 SR 23 mg (Extension)
n=19 participants at risk
E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg (Extension)
n=23 participants at risk
E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
|---|---|---|---|---|
|
Nervous system disorders
Ataxia
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
0.00%
0/19 • Up to 54 weeks
|
4.3%
1/23 • Up to 54 weeks
|
Other adverse events
| Measure |
E2020 SR 23 mg (Double-blind)
n=22 participants at risk
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
|
E2020 10 mg (Double-blind)
n=23 participants at risk
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
|
E2020 SR 23 mg (Extension)
n=19 participants at risk
E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
E2020 10 mg (Extension)
n=23 participants at risk
E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
3/22 • Up to 54 weeks
|
4.3%
1/23 • Up to 54 weeks
|
10.5%
2/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Up to 54 weeks
|
4.3%
1/23 • Up to 54 weeks
|
0.00%
0/19 • Up to 54 weeks
|
30.4%
7/23 • Up to 54 weeks
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22 • Up to 54 weeks
|
4.3%
1/23 • Up to 54 weeks
|
0.00%
0/19 • Up to 54 weeks
|
30.4%
7/23 • Up to 54 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
9.1%
2/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Investigations
Weight decreased
|
9.1%
2/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
15.8%
3/19 • Up to 54 weeks
|
4.3%
1/23 • Up to 54 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.3%
6/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
15.8%
3/19 • Up to 54 weeks
|
17.4%
4/23 • Up to 54 weeks
|
|
Nervous system disorders
Somnolence
|
9.1%
2/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
17.4%
4/23 • Up to 54 weeks
|
|
Eye disorders
Eye Discharge
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Gastrointestinal disorders
Epulis
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
General disorders
Oedema
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Investigations
Blood pressure decreased
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Investigations
Blood uric acid increased
|
4.5%
1/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
5.3%
1/19 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Up to 54 weeks
|
0.00%
0/23 • Up to 54 weeks
|
0.00%
0/19 • Up to 54 weeks
|
8.7%
2/23 • Up to 54 weeks
|
Additional Information
Naoki Kubota
Clinical Development. JAC PCU. 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