Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's D… (NCT01735630) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
United States350 participantsStarted 2012-11
Plain-language 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
Who can participate
Age range50 Years – 95 Years
SexALL
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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.
What they're measuring
1
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).