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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT01735630

Run by

OPKO Health, Inc.

People needed

350

Starts

2012-11-01

Expected to finish

2015-05-01

Last updated by the study team

2019-10-21

Who can join

Age: 50 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• TransitionTIL Investigational Site — Phoenix, Arizona, United States
• TransitionTIL Investigational Site — Phoenix, Arizona, United States
• TransitionTIL Investigational Site — Encino, California, United States
• TransitionTIL Investigational Site — Escondido, California, United States
• TransitionTIL Investigational Site — Fresno, California, United States
• TransitionTIL Investigational Site — Irvine, California, United States
• TransitionTIL Investigational Site — Long Beach, California, United States
• TransitionTIL Investigational Site — Los Alamitos, California, United States
• TransitionTIL Investigational Site — Los Angeles, California, United States
• TransitionTIL Investigational Site — Newport Beach, California, United States
• TransitionTIL Investigational Site — Santa Ana, California, United States
• TransitionTIL Investigational Site — Norwalk, Connecticut, United States
• TransitionTIL Investigational Site — Washington D.C., District of Columbia, United States
• TransitionTIL Investigational Site — Atlantis, Florida, United States
• TransitionTIL Investigational Site — Deerfield Beach, Florida, United States
• TransitionTIL Investigational Site — Delray Beach, Florida, United States
• TransitionTIL Investigational Site — Lake Worth, Florida, United States
• TransitionTIL Investigational Site — Miami, Florida, United States
• TransitionTIL Investigational Site — Oakland Park, Florida, United States
• TransitionTIL Investigational Site — Orlando, Florida, United States
• TransitionTIL Investigational Site — Ormond Beach, Florida, United States
• TransitionTIL Investigational Site — Port Charlotte, Florida, United States
• TransitionTIL Investigational Site — Sarasota, Florida, United States
• TransitionTIL Investigational Site — Sunrise, Florida, United States
• TransitionTIL Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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