Phase 2
Completed N=350
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Source: ClinicalTrials.gov NCT01735630 ↗Enrolled (actual)
350
Serious AEs
6.3%
Results posted
Aug 2016
Primary outcomePrimary: Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). — -4.3; -4.2 units on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). |
-4.3; -4.2 | — |
| SECONDARY Change From Baseline in Modified-ADCS-CGIC Agitation Scores |
3.6; 3.4 | — |
| SECONDARY Change From Baseline in NPI Total Scores |
-14.38; -15.12 | — |
| SECONDARY Change From Baseline in MMSE Scores |
-0.3; -0.4 | — |
| SECONDARY Change From Baseline in ADCS-ADL Scores |
-1.458; -2.229 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's Association (NIA-AA) guidelines (McKhann et al 2011).
- MMSE score of 5 to 24 (inclusive) at the Screening Visit.
- Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4.
- No response or suboptimal response to standard nonpharmacological interventions.
Exclusion Criteria
- The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.
- Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR).
- Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.
Data sourced from ClinicalTrials.gov (NCT01735630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.