Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT01735630|
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : August 15, 2016
Last Update Posted : October 21, 2019
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735630