ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: ELND005 (scyllo-inositol)

• Registration Number: NCT00934050
• Lead Sponsor: OPKO Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2015-04-22
• Results First Submitted QC: 2015-05-12
• Results First Posted: 2015-05-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELND005	ELND005 (scyllo-inositol)	-

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events (TEAEs)	12 months	Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

Trial Locations

Locations (38)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

University of Arizona, Health Sciences Center, Dept. of Neurology; 🇺🇸 Tucson, Arizona, United States

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

Collaborative NeuroScience Network, Inc.; 🇺🇸 Garden Grove, California, United States

Yale University School of Medicine, Alzheimer's Disease Research Unit; 🇺🇸 New Haven, Connecticut, United States

Brain Matters Research; 🇺🇸 Delray Beach, Florida, United States

Sunrise Clinical Research, Inc; 🇺🇸 Hollywood, Florida, United States

Roskamp Institute; 🇺🇸 Sarasota, Florida, United States

Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

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