Alzheimer's Disease Clinical Trial
Official title:
A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
| NCT number | NCT00934050 |
| Other study ID # | ELND005-AD251 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | June 2009 |
| Est. completion date | June 2011 |
| Verified date | October 2019 |
| Source | OPKO Health, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Glenrose Rehabilitation Hospital | Edmonton | Alberta |
| Canada | Parkwood Hospital | London | Ontario |
| Canada | Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont) | Montreal | Quebec |
| Canada | Sisters of Charity of Ottawa Health Service | Ottawa | Ontario |
| Canada | Kawartha Regional Memory Clinic | Peterborough | Ontario |
| Canada | Gerontion Research, Inc. | Toronto | Ontario |
| Canada | Whitby Mental Health Memory Clinic | Toronto | Ontario |
| Canada | University of British Columbia Hospital, Division of Neurology | Vancouver | British Columbia |
| United States | Neurological Associates of Albany, PC | Albany | New York |
| United States | Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico |
| United States | Emory University, Dept. of Neurology | Atlanta | Georgia |
| United States | Clinical Neuroscience Research Associates, Inc-The Memory Clinic | Bennington | Vermont |
| United States | Dekalb Neurology Associates, LLC | Decatur | Georgia |
| United States | Brain Matters Research | Delray Beach | Florida |
| United States | Memory Enhancement Center of America, Inc. | Eatontown | New Jersey |
| United States | Margolin Brain Institute | Fresno | California |
| United States | Collaborative NeuroScience Network, Inc. | Garden Grove | California |
| United States | Alliance for Neuro Research, LLC dba Absher Neurology, PA | Greenville | South Carolina |
| United States | Sunrise Clinical Research, Inc | Hollywood | Florida |
| United States | Department of Neurology - Indiana University Medical Center | Indianapolis | Indiana |
| United States | The Clinical Trial Center, LLC | Jenkintown | Pennsylvania |
| United States | University of Kansas Medical Center, Department of Neurology | Kansas City | Kansas |
| United States | Medford Neurological and Spine Clinic | Medford | Oregon |
| United States | Yale University School of Medicine, Alzheimer's Disease Research Unit | New Haven | Connecticut |
| United States | Columbia University Sergievsky Center | New York | New York |
| United States | Innovative Clinical Concepts | Paducah | Kentucky |
| United States | Banner Alzheimer's Institute | Phoenix | Arizona |
| United States | University of Pittsburgh Alzheimer Disease Research Clinic | Pittsburgh | Pennsylvania |
| United States | Summit Research Newtwork, Inc. | Portland | Oregon |
| United States | Global Medical Institutes | Princeton | New Jersey |
| United States | Butler Hospital, Memory and Aging Center | Providence | Rhode Island |
| United States | Raleigh Neurology Associates | Raleigh | North Carolina |
| United States | AD-CARE, Monroe Community Hospital | Rochester | New York |
| United States | Roskamp Institute | Sarasota | Florida |
| United States | Sun Health Research Institute | Sun City | Arizona |
| United States | Neurology & Neuroscience Center of Ohio | Toledo | Ohio |
| United States | University of Arizona, Health Sciences Center, Dept. of Neurology | Tucson | Arizona |
| United States | Premiere Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| OPKO Health, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment Emergent Adverse Events (TEAEs) | Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs) | 12 months |
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