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ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00934050
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ELND005 (scyllo-inositol) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
Study Start Date : June 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Experimental: ELND005 Drug: ELND005 (scyllo-inositol)

Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks

After 15Dec2009: ELND005 250 mg PO BID for 48 weeks

Other Name: scyllo-inositol

Primary Outcome Measures :
  1. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
    Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00934050

  Hide Study Locations
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United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Sun Health Research Institute
Sun City, Arizona, United States, 85351
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson, Arizona, United States, 85724
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
United States, Connecticut
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, United States, 06510
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Sunrise Clinical Research, Inc
Hollywood, Florida, United States, 33021
Roskamp Institute
Sarasota, Florida, United States, 34243
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University, Dept. of Neurology
Atlanta, Georgia, United States, 30329
Dekalb Neurology Associates, LLC
Decatur, Georgia, United States, 30033
United States, Indiana
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States, 66160
United States, Kentucky
Innovative Clinical Concepts
Paducah, Kentucky, United States, 42003
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Global Medical Institutes
Princeton, New Jersey, United States, 08540
United States, New Mexico
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States, 87109
United States, New York
Neurological Associates of Albany, PC
Albany, New York, United States, 12208
Columbia University Sergievsky Center
New York, New York, United States, 10032
AD-CARE, Monroe Community Hospital
Rochester, New York, United States, 14620
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oregon
Medford Neurological and Spine Clinic
Medford, Oregon, United States, 97504
Summit Research Newtwork, Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
University of Pittsburgh Alzheimer Disease Research Clinic
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Butler Hospital, Memory and Aging Center
Providence, Rhode Island, United States, 02906
United States, South Carolina
Alliance for Neuro Research, LLC dba Absher Neurology, PA
Greenville, South Carolina, United States, 29615
United States, Vermont
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington, Vermont, United States, 05201
Canada, Alberta
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T5G 0B7
Canada, British Columbia
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Sisters of Charity of Ottawa Health Service
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H 2P4
Whitby Mental Health Memory Clinic
Toronto, Ontario, Canada, M5T 2S8
Gerontion Research, Inc.
Toronto, Ontario, Canada, M6M 3Z5
Canada, Quebec
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Transition Therapeutics Ireland Limited
Transition Therapeutics

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Responsible Party: Transition Therapeutics Ireland Limited Identifier: NCT00934050     History of Changes
Other Study ID Numbers: ELND005-AD251
First Posted: July 8, 2009    Key Record Dates
Results First Posted: May 13, 2015
Last Update Posted: May 13, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs