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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO Health, Inc.; Transition Therapeutics Ireland Limited
• Collaborator: Elan Pharmaceuticals
• Treatments: Inositol

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.