ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
This study has been completed.
Sponsor:
Transition Therapeutics Ireland Limited
Collaborator:
Transition Therapeutics
Information provided by (Responsible Party):
Transition Therapeutics Ireland Limited
ClinicalTrials.gov Identifier:
NCT00934050
First received: June 29, 2009
Last updated: May 12, 2015
Last verified: May 2015
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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: 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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Drug Information available for:
Inositol
U.S. FDA Resources
Further study details as provided by Transition Therapeutics Ireland Limited:
Primary Outcome Measures:
- Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Show 38 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | June 29, 2009 |
| Results First Received: | April 22, 2015 |
| Last Updated: | May 12, 2015 |
| 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 Neurocognitive Disorders |
Mental Disorders Inositol Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016