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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.
 
ClinicalTrials.gov Identifier: NCT00934050
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : May 13, 2015
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Description
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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
Allocation: N/A
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

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

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
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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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


Locations
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Sponsors and Collaborators
OPKO Health, Inc.
More Information
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT00934050    
Other Study ID Numbers: ELND005-AD251
First Posted: July 8, 2009    Key Record Dates
Results First Posted: May 13, 2015
Last Update Posted: October 21, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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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
Physiological Effects of Drugs