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

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT01735630
First received: November 25, 2012
Last updated: July 6, 2016
Last verified: July 2016

November 25, 2012
July 6, 2016
November 2012
May 2015   (final data collection date for primary outcome measure)
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.
Change from Baseline in NPI-C combined agitation and aggression subscores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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 ]
    The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.
  • Change From Baseline in NPI Total Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.
  • Change From Baseline in MMSE Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.
  • Change From Baseline in ADCS-ADL Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.
  • 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 ]
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.
 
Completed
350
May 2015
May 2015   (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 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.
Both
50 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Spain,   United Kingdom
 
NCT01735630
ELND005-AG201, 2012-004299-20
No
Not Provided
Not Provided
Transition Therapeutics Ireland Limited
Transition Therapeutics Ireland Limited
Elan Pharmaceuticals
Not Provided
Transition Therapeutics Ireland Limited
July 2016

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