ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: ELND005 (scyllo-inositol) | Phase 2 |
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 |

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 |
- Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

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 |
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 |