Clinical trial NCT00934050: ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Official title: A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.


Eligibility criteria: Inclusion Criteria:

* This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

Exclusion Criteria:

* Subject has no new medical contraindications to continued participation in the study.

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona, Health Sciences Center, Dept. of Neurology
state: Arizona
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network, Inc.
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine, Alzheimer's Disease Research Unit
state: Connecticut
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University, Dept. of Neurology
state: Georgia
city: Decatur
country: United States
facility: Dekalb Neurology Associates, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Department of Neurology - Indiana University Medical Center
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Department of Neurology
state: Kansas
city: Paducah
country: United States
facility: Innovative Clinical Concepts
state: Kentucky
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: New York
country: United States
facility: Columbia University Sergievsky Center
state: New York
city: Rochester
country: United States
facility: AD-CARE, Monroe Community Hospital
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Medford
country: United States
facility: Medford Neurological and Spine Clinic
state: Oregon
city: Portland
country: United States
facility: Summit Research Newtwork, Inc.
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Alzheimer Disease Research Clinic
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital, Memory and Aging Center
state: Rhode Island
city: Greenville
country: United States
facility: Alliance for Neuro Research, LLC dba Absher Neurology, PA
state: South Carolina
city: Bennington
country: United States
facility: Clinical Neuroscience Research Associates, Inc-The Memory Clinic
state: Vermont
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia Hospital, Division of Neurology
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Sisters of Charity of Ottawa Health Service
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Whitby Mental Health Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Gerontion Research, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
state: Quebec
Study officials:
References: