ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
1 other identifier
interventional
103
2 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
May 13, 2015
CompletedOctober 21, 2019
October 1, 2019
2 years
June 29, 2009
April 22, 2015
October 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Emergent Adverse Events (TEAEs)
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
12 months
Study Arms (1)
ELND005
EXPERIMENTALInterventions
Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks After 15Dec2009: ELND005 250 mg PO BID for 48 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subject has no new medical contraindications to continued participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, 85724, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Collaborative NeuroScience Network, Inc.
Garden Grove, California, 92845, United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Sunrise Clinical Research, Inc
Hollywood, Florida, 33021, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Emory University, Dept. of Neurology
Atlanta, Georgia, 30329, United States
Dekalb Neurology Associates, LLC
Decatur, Georgia, 30033, United States
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, 66160, United States
Innovative Clinical Concepts
Paducah, Kentucky, 42003, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Global Medical Institutes
Princeton, New Jersey, 08540, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
Neurological Associates of Albany, PC
Albany, New York, 12208, United States
Columbia University Sergievsky Center
New York, New York, 10032, United States
AD-CARE, Monroe Community Hospital
Rochester, New York, 14620, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Medford Neurological and Spine Clinic
Medford, Oregon, 97504, United States
Summit Research Newtwork, Inc.
Portland, Oregon, 97210, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
University of Pittsburgh Alzheimer Disease Research Clinic
Pittsburgh, Pennsylvania, 15213, United States
Butler Hospital, Memory and Aging Center
Providence, Rhode Island, 02906, United States
Alliance for Neuro Research, LLC dba Absher Neurology, PA
Greenville, South Carolina, 29615, United States
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington, Vermont, 05201, United States
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7, Canada
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, V6T 2B5, Canada
Parkwood Hospital
London, Ontario, N6C 5J1, Canada
Sisters of Charity of Ottawa Health Service
Ottawa, Ontario, K1N 5C8, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4, Canada
Whitby Mental Health Memory Clinic
Toronto, Ontario, M5T 2S8, Canada
Gerontion Research, Inc.
Toronto, Ontario, M6M 3Z5, Canada
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan Abushakra, MD, Chief Medical Officer
- Organization
- Transition Therapeutics Ireland Limited and Transition Therapeutics USA Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 8, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
October 21, 2019
Results First Posted
May 13, 2015
Record last verified: 2019-10