Alzheimer's Disease | Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Alzheimer's Disease research study
What is the primary objective of this study?
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 is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ELND005ELND005 film coated tablets, BID for 12 weeks
PlaceboMatched placebo BID for 12 weeks
Start Date: November 2012
Completed Date: May 2015
Phase: Phase 2
Primary Outcome: Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
Secondary Outcome: Change From Baseline in Modified-ADCS-CGIC Agitation Scores
Study sponsors, principal investigator, and references
Lead Sponsor: Transition Therapeutics Ireland Limited
Collaborator: Elan Pharmaceuticals