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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?

Alzheimer's Disease

Study Interventions

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.

Drug:ELND005

Drug:Placebo

Study Arms

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

Study Status

Completed

Start Date: November 2012

Completed Date: May 2015

Phase: Phase 2

Type: Interventional

Design:

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

Principal Investigator:

Lead Sponsor: Transition Therapeutics Ireland Limited

Collaborator: Elan Pharmaceuticals

More information:https://clinicaltrials.gov/show/NCT01735630

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