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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glenrose Rehabilitation Hospital, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ELND005 (scyllo-inositol)

Drug

Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks

After 15Dec2009: ELND005 250 mg PO BID for 48 weeks

Other names: scyllo-inositol

Primary outcomes

Treatment Emergent Adverse Events (TEAEs)

Time frame: 12 months

Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jul 8, 2009
Registry last updated: Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed