Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01735630|
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: ELND005 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
ELND005 film coated tablets, BID for 12 weeks
Other Name: Scyllo-inositol
Placebo Comparator: Placebo
Matched placebo BID for 12 weeks
- Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A). [ Time Frame: Week 12 ]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 Modified-ADCS-CGIC Agitation Scores [ Time Frame: Week 12 ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735630
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