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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735630
• Other study ID #: ELND005-AG201
• Secondary ID: 2012-004299-20
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2019
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Alzheimer Disease
• Alzheimer's Disease
• Psychomotor Agitation

Intervention

Drug:
• ELND005

• Placebo

Locations

Country	Name	City	State
Canada	TransitionTIL Investigational Site	Calgary	Alberta
Canada	TransitionTIL Investigational Site	Kelowna	British Columbia
Canada	TransitionTIL Investigational Site	Regina	Saskatchewan
Canada	TransitionTIL Investigational Site	Toronto	Ontario
Canada	TransitionTIL Investigational Site	Toronto	Ontario
Spain	TransitionTIL Investigational Site	Barcelona
Spain	TransitionTIL Investigational Site	Barcelona
Spain	TransitionTIL Investigational Site	Burgos
Spain	TransitionTIL Investigational Site	Elche	Alicante
Spain	TransitionTIL Investigational Site	Getxo	Biscay
Spain	TransitionTIL Investigational Site	Madrid
United Kingdom	TransitionTIL Investigational Site	Bath
United Kingdom	TransitionTIL Investigational Site	Swindon
United States	TransitionTIL Investigational Site	Abington	Pennsylvania
United States	TransitionTIL Investigational Site	Ann Arbor	Michigan
United States	TransitionTIL Investigational Site	Atlantis	Florida
United States	TransitionTIL Investigational Site	Bangor	Maine
United States	TransitionTIL Investigational Site	Bellevue	Washington
United States	TransitionTIL Investigational Site	Birmingham	Alabama
United States	TransitionTIL Investigational Site	Charlotte	North Carolina
United States	TransitionTIL Investigational Site	Charlotte	North Carolina
United States	TransitionTIL Investigational Site	Columbus	Georgia
United States	TransitionTIL Investigational Site	Deerfield Beach	Florida
United States	TransitionTIL Investigational Site	Delray Beach	Florida
United States	TransitionTIL Investigational Site	DeSoto	Texas
United States	TransitionTIL Investigational Site	Durham	North Carolina
United States	TransitionTIL Investigational Site	Easton	Maryland
United States	TransitionTIL Investigational Site	Encino	California
United States	TransitionTIL Investigational Site	Escondido	California
United States	TransitionTIL Investigational Site	Fresno	California
United States	TransitionTIL Investigational Site	Hattiesburg	Mississippi
United States	TransitionTIL Investigational Site	Irvine	California
United States	TransitionTIL Investigational Site	Jenkintown	Pennsylvania
United States	TransitionTIL Investigational Site	Lake Worth	Florida
United States	TransitionTIL Investigational Site	Long Beach	California
United States	TransitionTIL Investigational Site	Los Alamitos	California
United States	TransitionTIL Investigational Site	Los Angeles	California
United States	TransitionTIL Investigational Site	Miami	Florida
United States	TransitionTIL Investigational Site	Nashville	Tennessee
United States	TransitionTIL Investigational Site	Newport Beach	California
United States	TransitionTIL Investigational Site	Norristown	Pennsylvania
United States	TransitionTIL Investigational Site	North Charleston	South Carolina
United States	TransitionTIL Investigational Site	Norwalk	Connecticut
United States	TransitionTIL Investigational Site	Oakland Park	Florida
United States	TransitionTIL Investigational Site	Oklahoma City	Oklahoma
United States	TransitionTIL Investigational Site	Orlando	Florida
United States	TransitionTIL Investigational Site	Ormond Beach	Florida
United States	TransitionTIL Investigational Site	Paw Paw	Michigan
United States	TransitionTIL Investigational Site	Philadelphia	Pennsylvania
United States	TransitionTIL Investigational Site	Philadelphia	Pennsylvania
United States	TransitionTIL Investigational Site	Phoenix	Arizona
United States	TransitionTIL Investigational Site	Phoenix	Arizona
United States	TransitionTIL Investigational Site	Pittsburgh	Pennsylvania
United States	TransitionTIL Investigational Site	Port Charlotte	Florida
United States	TransitionTIL Investigational Site	Port Royal	South Carolina
United States	TransitionTIL Investigational Site	Portland	Oregon
United States	TransitionTIL Investigational Site	Richmond	Virginia
United States	TransitionTIL Investigational Site	Rochester	New York
United States	TransitionTIL Investigational Site	Rochester	New York
United States	TransitionTIL Investigational Site	Saint Paul	Minnesota
United States	TransitionTIL Investigational Site	Santa Ana	California
United States	TransitionTIL Investigational Site	Sarasota	Florida
United States	TransitionTIL Investigational Site	Savannah	Georgia
United States	TransitionTIL Investigational Site	Springfield	Illinois
United States	TransitionTIL Investigational Site	Stratford	New Jersey
United States	TransitionTIL Investigational Site	Sunrise	Florida
United States	TransitionTIL Investigational Site	Washington	District of Columbia
United States	TransitionTIL Investigational Site	Wilmington	North Carolina
United States	TransitionTIL Investigational Site	Winchester	Massachusetts
United States	TransitionTIL Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
OPKO Health, Inc.	Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).	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.	Week 12
Secondary	Change From Baseline in Modified-ADCS-CGIC Agitation Scores	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.	Week 12
Secondary	Change From Baseline in NPI Total Scores	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.	Week 12
Secondary	Change From Baseline in MMSE Scores	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.	Week 12
Secondary	Change From Baseline in ADCS-ADL Scores	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.	Week 12