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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
History of Changes
  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:

Drug Information available for: Inositol
U.S. FDA Resources

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

  Show 38 Study Locations
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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013