Clinical trial NCT01766336: A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Official title: A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Agitation
Aggression
AD patients
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2013-01-11
Enrollment: 296
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: To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.


Eligibility criteria: Inclusion Criteria:

* Complete Week 12 visit of AG201
* Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests

Exclusion Criteria:

* Is currently using any other investigational or experimental drugs or devices
* Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study

Primary outcomes:
measure: Number of Participants Experiencing Treatment Emergent Adverse Events
timeFrame: 36 weeks
Secondary outcomes:
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: Long Beach
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Newport Beach
country: United States
facility: TransitionTIL Investigational Site
state: California
city: Orange
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: Oakland Park
country: United States
facility: TransitionTIL Investigational Site
state: Florida
city: Orlando
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: 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: Easton
country: United States
facility: TransitionTIL Investigational Site
state: Maryland
city: Winchester
country: United States
facility: TransitionTIL Investigational Site
state: Massachusetts
city: Saint Paul
country: United States
facility: TransitionTIL Investigational Site
state: Minnesota
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: 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: Pittsburgh
country: United States
facility: TransitionTIL Investigational Site
state: Pennsylvania
city: Port Royal
country: United States
facility: TransitionTIL Investigational Site
state: South Carolina
city: DeSoto
country: United States
facility: TransitionTIL Investigational Site
state: Texas
city: Bellevue
country: United States
facility: TransitionTIL Investigational Site
state: Washington
city: Toronto
country: Canada
facility: TransitionTIL Investigational Site
state: Ontario
city: Elche
country: Spain
facility: TransitionTIL Investigational Site
state: Alicante
city: Terrassa
country: Spain
facility: TransitionTIL Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: TransitionTIL Investigational Site
city: Madrid
country: Spain
facility: TransitionTIL Investigational Site
city: Swindon
country: United Kingdom
facility: TransitionTIL Investigational Site
state: Wiltshire
Study officials:
References: