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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 December 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: December 2, 2013
Last verified: December 2013

November 25, 2012
December 2, 2013
November 2012
December 2013   (final data collection date for primary outcome measure)
Change from Baseline in NPI-C combined agitation and aggression subscores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01735630 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: ELND005
    Other Name: Scyllo-inositol
  • Drug: Placebo
  • Experimental: ELND005
    ELND005 film coated tablets, BID for 12 weeks
    Intervention: Drug: ELND005
  • Placebo Comparator: Placebo
    Matched placebo BID for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
December 2013   (final data collection date for primary outcome measure)

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 8 to 23 (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.
Both
50 Years to 88 Years
No
Contact: US and Canada: Call Center 1-866 395 2121
Contact: Europe: Lisa Parsons +1 503-475-0631
United States,   Canada,   Spain,   United Kingdom
 
NCT01735630
ELND005-AG201, 2012-004299-20
Not Provided
Elan Pharmaceuticals ( Elan Pharma International Limited )
Elan Pharma International Limited
Elan Pharmaceuticals
Not Provided
Elan Pharmaceuticals
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP