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

OPKO Health

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: ELND005

Study type: Interventional

Funder types: Industry

Identifiers

NCT01735630

2012-004299-20 (EudraCT Number)

ELND005-AG201

Details and patient eligibility

About

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

Enrollment: 350 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups, including a placebo group

ELND005

Experimental group

Description:

ELND005 film coated tablets, BID for 12 weeks

Treatment:

Drug: ELND005

Placebo

Placebo Comparator group

Description:

Matched placebo BID for 12 weeks

Treatment:

Drug: Placebo