At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 350 enrolled
Drug / intervention
ELND005 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Probable Alzheimer's Disease diagnosis per NIA-AA guidelines
- ✓MMSE score 5 to 24 (cognitive severity range)
- ✓Clinically significant agitation/aggression (NPI-agitation/aggression subscore ≥4)
- ✓Failed or inadequate response to standard nonpharmacological interventions
Key exclusion· 3
- ✕Agitation/aggression attributable to concomitant medications, environmental factors, or active medical/psychiatric conditions
- ✕Current major depressive disorder diagnosis (DSM-IV-TR)
- ✕Persistent, distressing psychotic symptoms (delusions/hallucinations) requiring psychiatric hospitalization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
In Brief
A Phase 2 clinical trial evaluating ELND005 and Placebo for Alzheimer's Disease. Completed, enrolled 350 participants across 70 sites in 4 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesCanada, Spain, United Kingdom, United States
CollaboratorsElan Pharmaceuticals
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionMay 2015
TodayJul 2026
First PostedNov 28, 2012
Enrollment StartNov 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.6 years ago
Interventions
ELND005drug
Placebodrug