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

This study is currently recruiting participants.
Verified May 2013 by Elan Pharmaceuticals
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier:
NCT01735630
First received: November 25, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
 Drug: ELND005
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Change from Baseline in NPI-C combined agitation and aggression subscores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in modified-ADCS-CGIC agitation scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in NPI total scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in MMSE scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in ADCS-ADL scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: over 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELND005
ELND005 film coated tablets, BID for 12 weeks
 Drug: ELND005
Other Name: Scyllo-inositol
Placebo Comparator: Placebo
Matched placebo BID for 12 weeks
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 10 to 21 (inclusive) at the Screening Visit.
  • Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥4, with a severity score of ≥2 and a frequency score of ≥2 at both the Screening and Baseline Visits.
  • 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).
  • Symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization.
  • Treated with oral antipsychotic medications within 2 weeks prior to the Screening Visit.
  • Treated with depot preparations of an antipsychotic within 3 months of the Screening Visit.
  • Screening Visit brain MRI scan abnormalities that can be attributed to diseases or processes other than AD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735630

Contacts
Contact: Barbara Gaunce 910-558-4645

  Show 50 Study Locations
Sponsors and Collaborators
Elan Pharma International Limited
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier: NCT01735630     History of Changes
Other Study ID Numbers: ELND005-AG201, 2012-004299-20
Study First Received: November 25, 2012
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Agitation
Aggression
patients

Additional relevant MeSH terms:
Aggression
Alzheimer Disease
Psychomotor Agitation
Behavioral Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013