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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: ELND005; Drug: Placebo

• Registration Number: NCT01735630
• Lead Sponsor: OPKO Health, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-25
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-04-07
• Results First Submitted QC: 2016-07-06
• Results First Posted: 2016-08-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ELND005	ELND005	ELND005 film coated tablets, BID for 12 weeks
Placebo	Placebo	Matched placebo BID for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Modified-ADCS-CGIC Agitation Scores	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	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	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	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.

Trial Locations

Locations (1)

TransitionTIL Investigational Site; 🇬🇧 Swindon, United Kingdom