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

October 17, 2019 updated by: OPKO Health, Inc.

A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5G 0B7
        • Glenrose Rehabilitation Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia Hospital, Division of Neurology
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital
      • Ottawa, Ontario, Canada, K1N 5C8
        • Sisters of Charity of Ottawa Health Service
      • Peterborough, Ontario, Canada, K9H 2P4
        • Kawartha Regional Memory Clinic
      • Toronto, Ontario, Canada, M5T 2S8
        • Whitby Mental Health Memory Clinic
      • Toronto, Ontario, Canada, M6M 3Z5
        • Gerontion Research, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Sun City, Arizona, United States, 85351
        • Sun Health Research Institute
      • Tucson, Arizona, United States, 85724
        • University of Arizona, Health Sciences Center, Dept. of Neurology
    • California
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine, Alzheimer's Disease Research Unit
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hollywood, Florida, United States, 33021
        • Sunrise Clinical Research, Inc
      • Sarasota, Florida, United States, 34243
        • Roskamp Institute
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University, Dept. of Neurology
      • Decatur, Georgia, United States, 30033
        • Dekalb Neurology Associates, LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Department of Neurology - Indiana University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center, Department of Neurology
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Innovative Clinical Concepts
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center of America, Inc.
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany, PC
      • New York, New York, United States, 10032
        • Columbia University Sergievsky Center
      • Rochester, New York, United States, 14620
        • AD-CARE, Monroe Community Hospital
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medford Neurological and Spine Clinic
      • Portland, Oregon, United States, 97210
        • Summit Research Newtwork, Inc.
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Alzheimer Disease Research Clinic
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital, Memory and Aging Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Alliance for Neuro Research, LLC dba Absher Neurology, PA
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Clinical Neuroscience Research Associates, Inc-The Memory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • scyllo-inositol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events (TEAEs)
Time Frame: 12 months
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELND005-AD251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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