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NCT01735630 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
A Phase 2 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 350
- Enrollment target
NCT01735630: Completed Phase 2 study, sponsored by OPKO Health.
NCT01735630 is a Phase 2 study that has completed, run by OPKO Health. The registered enrollment target is 350 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01735630, a Phase 2 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 350 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG ELND005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT01735630 record still lists
NCT01735630 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (163% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01735630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01735630 about?
NCT01735630 is a clinical study titled "Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease". The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease
What is the current status of trial NCT01735630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2012-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01735630?
The interventions under investigation include: Placebo (DRUG), ELND005 (DRUG).
Who is sponsoring clinical trial NCT01735630?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01735630's enrollment target sits among peer trials
350 130th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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