Phase 2 N=350 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01735630 ↗

Enrolled (actual)

350

Serious AEs

6.3%

Results posted

Aug 2016

Primary outcome: Primary: Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). — -4.3; -4.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ELND005 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: OPKO Health, Inc.
Primary completion: May 2015

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	—

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

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.

View full record on ClinicalTrials.gov →

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.