Trial · NCT00598650
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
NCT00598650, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2014-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies. Trials, record NCT00598650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00598650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
- NCT number
- NCT00598650
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Dementia With Lewy Bodies (DLB)
- Interventions
- E2020
- First posted
- 2008-01-22
- Last updated
- 2014-09-03
- Results first posted
- 2014-09-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mini-mental State Examination (MMSE) Total | Baseline, Week 52, and Week 52 LOCF | 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. |
| Primary | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Baseline, Week 52, and Week 52 LOCF | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mini-mental State Examination (MMSE) Total | Baseline, Week 52, and Week 52 LOCF | 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. | Score on a Scale | MEAN |
| PRIMARY | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Baseline, Week 52, and Week 52 LOCF | Efficacy Analysis Set | Score on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mini-mental State Examination (MMSE) Total | E2020 | Baseline | 20.9 | Standard Deviation 5.1 | Score on a Scale |
| Change From Baseline in Mini-mental State Examination (MMSE) Total | Placebo/E2020 | Baseline | 18.6 | Standard Deviation 4.7 | Score on a Scale |
| Change From Baseline in Mini-mental State Examination (MMSE) Total | E2020 | Week 52 | 0.3 | Standard Deviation 3.7 | Score on a Scale |
| Change From Baseline in Mini-mental State Examination (MMSE) Total | Placebo/E2020 | Week 52 | 2 | Standard Deviation 4.4 | Score on a Scale |
| Change From Baseline in Mini-mental State Examination (MMSE) Total | E2020 | Week 52 LOCF | 0.2 | Standard Deviation 3.5 | Score on a Scale |
| Change From Baseline in Mini-mental State Examination (MMSE) Total | Placebo/E2020 | Week 52 LOCF | 1.7 | Standard Deviation 4.4 | Score on a Scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | E2020 | Baseline | 13.1 | Standard Deviation 16.8 | Score on a Scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Placebo/E2020 | Baseline | 17.8 | Standard Deviation 8.2 | Score on a Scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | E2020 | Week 52 | -1.9 | Standard Deviation 9.8 | Score on a Scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Placebo/E2020 | Week 52 | -4.1 | Standard Deviation 10.1 | Score on a Scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | E2020 | 108 | |
| Overall Study | COMPLETED | E2020 | 81 | |
| Overall Study | NOT COMPLETED | E2020 | 27 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | E2020 | 11 | 108 | |
| other | Decreased appetite | Metabolism and nutrition disorders | E2020 | 6 | 108 | |
| other | Insomnia | Psychiatric disorders | E2020 | 6 | 108 | |
| other | Parkinsonism | Nervous system disorders | E2020 | 8 | 108 | |
| other | Diarrhoea | Gastrointestinal disorders | E2020 | 10 | 108 | |
| other | Constipation | Gastrointestinal disorders | E2020 | 8 | 108 | |
| other | Blood creatine phosphokinase increased | Investigations | E2020 | 12 | 108 | |
| other | Blood pressure increased | Investigations | E2020 | 11 | 108 | |
| other | Blood urine present | Investigations | E2020 | 7 | 108 | |
| other | Protein urine present | Investigations | E2020 | 7 | 108 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | E2020 | ||
| Total, other adverse events | E2020 | 53 | 108 |
| Total, serious adverse events | E2020 | 8 | 108 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00598650
GET https://conductscience.org/api/trials/v1/NCT00598650/events?page=2