Trial · NCT01735630
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
NCT01735630, Phase 2, Completed, OPKO Health, Inc.; results first posted 2016-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease. Trials, record NCT01735630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01735630
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
- NCT number
- NCT01735630
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 350 participants, actual
- Lead sponsor
- OPKO Health, Inc.
- Conditions
- Alzheimer's Disease
- Interventions
- ELND005, Placebo
- First posted
- 2012-11-28
- Last updated
- 2019-10-21
- Other registries' IDs
- eudract:2012-004299-20
- Results first posted
- 2016-08-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). | Week 12 | The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population. |
| Secondary | Change From Baseline in Modified-ADCS-CGIC Agitation Scores | Week 12 | The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation. |
| Secondary | Change From Baseline in NPI Total Scores | Week 12 | The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144. |
| Secondary | Change From Baseline in MMSE Scores | Week 12 | The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function. |
| Secondary | Change From Baseline in ADCS-ADL Scores | Week 12 | The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function. |
Source ClinicalTrials.gov
Outcomes5
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 NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). | Week 12 | mITT | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified-ADCS-CGIC Agitation Scores | Week 12 | mITT population with available data for Modified-ADCS-CGIC Agitation Scores | units on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI Total Scores | Week 12 | mITT population with available data for NPI Total Scores | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MMSE Scores | Week 12 | mITT population with available data for MMSE Scores | units on a scale | MEAN |
| SECONDARY | Change From Baseline in ADCS-ADL Scores | Week 12 | mITT population with available data for ADCS-ADL Scores | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
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 NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). | ELND005 | -4.3 | Standard Error 0.7 | units on a scale | |
| Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). | Placebo | -4.2 | Standard Error 0.7 | units on a scale | |
| Change From Baseline in Modified-ADCS-CGIC Agitation Scores | ELND005 | 3.6 | Standard Error 0.1 | units on a scale | |
| Change From Baseline in Modified-ADCS-CGIC Agitation Scores | Placebo | 3.4 | Standard Error 0.1 | units on a scale | |
| Change From Baseline in NPI Total Scores | ELND005 | -14.38 | Standard Error 1.69 | units on a scale | |
| Change From Baseline in NPI Total Scores | Placebo | -15.12 | Standard Error 1.71 | units on a scale | |
| Change From Baseline in MMSE Scores | ELND005 | -0.3 | Standard Error 0.2 | units on a scale | |
| Change From Baseline in MMSE Scores | Placebo | -0.4 | Standard Error 0.2 | units on a scale | |
| Change From Baseline in ADCS-ADL Scores | ELND005 | -1.458 | Standard Error 0.7 | units on a scale | |
| Change From Baseline in ADCS-ADL Scores | Placebo | -2.229 | Standard Error 0.7 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ELND005 | 175 | |
| Overall Study | STARTED | Placebo | 175 | |
| Overall Study | COMPLETED | ELND005 | 157 | |
| Overall Study | COMPLETED | Placebo | 157 | |
| Overall Study | NOT COMPLETED | ELND005 | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events82
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 | Agitation | Psychiatric disorders | ELND005 | 14 | 175 | |
| other | Agitation | Psychiatric disorders | Placebo | 13 | 175 | |
| other | Insomnia | Psychiatric disorders | ELND005 | 5 | 175 | |
| other | Insomnia | Psychiatric disorders | Placebo | 7 | 175 | |
| other | Diarrhoea | Gastrointestinal disorders | ELND005 | 14 | 175 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 175 | |
| other | Vomiting | Gastrointestinal disorders | ELND005 | 5 | 175 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 5 | 175 | |
| other | Constipation | Gastrointestinal disorders | ELND005 | 4 | 175 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 175 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ELND005 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ELND005 | 97 | 175 |
| Total, other adverse events | Placebo | 82 | 175 |
| Total, serious adverse events | ELND005 | 17 | 175 |
| Total, serious adverse events | Placebo | 5 | 175 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ELND005 vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01735630
GET https://conductscience.org/api/trials/v1/NCT01735630/events?page=2