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

This study has been completed.
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00934050
First received: June 29, 2009
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: ELND005 (scyllo-inositol)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability analyses will be based on the frequency and severity of adverse events and on clinically important changes in laboratory assessment results. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934050

  Hide Study Locations
Locations
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
Gerontion Research, Inc.
Toronto, Ontario, Canada, M6M 3Z5
Whitby Mental Health Memory Clinic
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Elan Pharmaceuticals
Transition Therapeutics
  More Information

No publications provided

Responsible Party: Jesse Cedarbaum, Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00934050     History of Changes
Other Study ID Numbers: ELND005-AD251
Study First Received: June 29, 2009
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Inositol
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014