Clinical trial NCT01735630: Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Agitation
Aggression
patients
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2012-11-28
Enrollment: 350
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Modified-ADCS-CGIC Agitation Scores
timeFrame: Week 12
measure: Change From Baseline in NPI Total Scores
timeFrame: Week 12
measure: Change From Baseline in MMSE Scores
timeFrame: Week 12
measure: Change From Baseline in ADCS-ADL Scores
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: TransitionTIL Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: TransitionTIL Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: TransitionTIL Investigational Site
state: Arizona
city: Encino
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Escondido
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Fresno
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Irvine
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Long Beach
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Los Alamitos
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Los Angeles
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Newport Beach
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Santa Ana
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Norwalk
country: United States
facility: TransitionTIL Investigational Site
state: Connecticut
city: Washington
country: United States
facility: TransitionTIL Investigational Site
state: District of Columbia
city: Atlantis
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Deerfield Beach
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Miami
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Orlando
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Sarasota
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Sunrise
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Columbus
country: United States
facility: TransitionTIL Investigational Site
state: Georgia
city: Savannah
country: United States
facility: TransitionTIL Investigational Site
state: Georgia
city: Springfield
country: United States
facility: TransitionTIL Investigational Site
state: Illinois
city: Bangor
country: United States
facility: TransitionTIL Investigational Site
state: Maine
city: Easton
country: United States
facility: TransitionTIL Investigational Site
state: Maryland
city: Winchester
country: United States
facility: TransitionTIL Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: TransitionTIL Investigational Site
state: Michigan
city: Paw Paw
country: United States
facility: TransitionTIL Investigational Site
state: Michigan
city: Saint Paul
country: United States
facility: TransitionTIL Investigational Site
state: Minnesota
city: Hattiesburg
country: United States
facility: TransitionTIL Investigational Site
state: Mississippi
city: Stratford
country: United States
facility: TransitionTIL Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: TransitionTIL Investigational Site
state: New York
city: Rochester
country: United States
facility: TransitionTIL Investigational Site
state: New York
city: Charlotte
country: United States
facility: TransitionTIL Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: TransitionTIL Investigational Site
state: North Carolina
city: Durham
country: United States
facility: TransitionTIL Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: TransitionTIL Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: TransitionTIL Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: TransitionTIL Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: TransitionTIL Investigational Site
state: Oregon
city: Abington
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: North Charleston
country: United States
facility: TransitionTIL Investigational Site
state: South Carolina
city: Port Royal
country: United States
facility: TransitionTIL Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: TransitionTIL Investigational Site
state: Tennessee
city: DeSoto
country: United States
facility: TransitionTIL Investigational Site
state: Texas
city: Richmond
country: United States
facility: TransitionTIL Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: TransitionTIL Investigational Site
state: Washington
city: Calgary
country: Canada
facility: TransitionTIL Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: TransitionTIL Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: TransitionTIL Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: TransitionTIL Investigational Site
state: Ontario
city: Regina
country: Canada
facility: TransitionTIL Investigational Site
state: Saskatchewan
city: Elche
country: Spain
facility: TransitionTIL Investigational Site
state: Alicante
city: Getxo
country: Spain
facility: TransitionTIL Investigational Site
state: Biscay
city: Barcelona
country: Spain
facility: TransitionTIL Investigational Site
city: Barcelona
country: Spain
facility: TransitionTIL Investigational Site
city: Burgos
country: Spain
facility: TransitionTIL Investigational Site
city: Madrid
country: Spain
facility: TransitionTIL Investigational Site
city: Bath
country: United Kingdom
facility: TransitionTIL Investigational Site
city: Swindon
country: United Kingdom
facility: TransitionTIL Investigational Site
Study officials:
References: