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

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ClinicalTrials.gov Identifier: NCT00934050
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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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
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00934050


  Show 38 Study Locations
Sponsors and Collaborators
Transition Therapeutics Ireland Limited
Transition Therapeutics
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Transition Therapeutics Ireland Limited
ClinicalTrials.gov 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:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs