A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

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

A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

296

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
    • Ontario
      • Toronto, Ontario, Canada, M6M 3Z5
        • TransitionTIL Investigational Site
  • Spain
      • Barcelona, Spain, 08028
        • TransitionTIL Investigational Site
      • Madrid, Spain, 28040
        • TransitionTIL Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • TransitionTIL Investigational Site
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • TransitionTIL Investigational Site
  • United Kingdom
    • Wiltshire
      • Swindon, Wiltshire, United Kingdom, SN3 6BW
        • TransitionTIL Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • TransitionTIL Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • TransitionTIL Investigational Site
      • Phoenix, Arizona, United States, 85006
        • TransitionTIL Investigational Site
    • California
      • Encino, California, United States, 91316
        • TransitionTIL Investigational Site
      • Escondido, California, United States, 92025
        • TransitionTIL Investigational Site
      • Fresno, California, United States, 93710
        • TransitionTIL Investigational Site
      • Long Beach, California, United States, 90806
        • TransitionTIL Investigational Site
      • Newport Beach, California, United States, 92658
        • TransitionTIL Investigational Site
      • Orange, California, United States, 92868
        • TransitionTIL Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • TransitionTIL Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • TransitionTIL Investigational Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • TransitionTIL Investigational Site
      • Deerfield Beach, Florida, United States, 33064
        • TransitionTIL Investigational Site
      • Delray Beach, Florida, United States, 33445
        • TransitionTIL Investigational Site
      • Lake Worth, Florida, United States, 33449
        • TransitionTIL Investigational Site
      • Oakland Park, Florida, United States, 33334
        • TransitionTIL Investigational Site
      • Orlando, Florida, United States, 32806
        • TransitionTIL Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • TransitionTIL Investigational Site
      • Sarasota, Florida, United States, 34243
        • TransitionTIL Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31909
        • TransitionTIL Investigational Site
      • Savannah, Georgia, United States, 31419
        • TransitionTIL Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62702
        • TransitionTIL Investigational Site
    • Maryland
      • Easton, Maryland, United States, 21601
        • TransitionTIL Investigational Site
    • Massachusetts
      • Winchester, Massachusetts, United States, 01890
        • TransitionTIL Investigational Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • TransitionTIL Investigational Site
    • New York
      • Rochester, New York, United States, 14620
        • TransitionTIL Investigational Site
      • Rochester, New York, United States, 14623
        • TransitionTIL Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • TransitionTIL Investigational Site
      • Durham, North Carolina, United States, 27710
        • TransitionTIL Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • TransitionTIL Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • TransitionTIL Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • TransitionTIL Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97225-6625
        • TransitionTIL Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • TransitionTIL Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • TransitionTIL Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • TransitionTIL Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • TransitionTIL Investigational Site
    • South Carolina
      • Port Royal, South Carolina, United States, 29935
        • TransitionTIL Investigational Site
    • Texas
      • DeSoto, Texas, United States, 75115
        • TransitionTIL Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • TransitionTIL Investigational Site

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

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete Week 12 visit of AG201
  • Both patient and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests

Exclusion Criteria:

  • Is currently using any other investigational or experimental drugs or devices
  • Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 ELND005/ELND005
Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.
Drug: Group 1 ELND005
Experimental: Group 2 PLACEBO/ELND005
Patients who received placebo during Study AG201 will receive ELND005 at the same dosing regimen as the active group in Study AG201 for 36 weeks.
Drug: Group 2 ELND005

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Treatment Emergent Adverse Events
Time Frame: 36 weeks
To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.
36 weeks

Collaborators and Investigators

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

Sponsor

OPKO Health, Inc.

Collaborators

Elan Pharmaceuticals

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

January 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 11, 2013

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELND005-AG251
  • 2012-005524-15 (EudraCT Number)

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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