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Trial record 1 of 6 for:    elnd005
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ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00934050
First Posted: July 8, 2009
Last Update Posted: May 13, 2015
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.
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
  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: 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

Resource links provided by NLM:


Further study details as provided by Transition Therapeutics Ireland Limited:

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


Enrollment: 103
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

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
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

Responsible Party: Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier: NCT00934050     History of Changes
Other Study ID Numbers: ELND005-AD251
First Submitted: June 29, 2009
First Posted: July 8, 2009
Results First Submitted: April 22, 2015
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