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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Group 1 ELND005
Group 2 ELND005
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Agitation, Aggression, AD patients

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site
  • TransitionTIL Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 ELND005/ELND005

Group 2 PLACEBO/ELND005

Arm Description

Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.

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.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Treatment Emergent Adverse Events
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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2013
Last Updated
October 17, 2019
Sponsor
OPKO Health, Inc.
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01766336
Brief Title
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Official Title
A 36-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.
Collaborators
Elan Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Agitation, Aggression, AD patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 ELND005/ELND005
Arm Type
Experimental
Arm Description
Patients who received ELND005 during Study AG201 will continue on the same maintenance dose for 36 weeks.
Arm Title
Group 2 PLACEBO/ELND005
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Group 1 ELND005
Intervention Type
Drug
Intervention Name(s)
Group 2 ELND005
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment Emergent Adverse Events
Description
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.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TransitionTIL Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6625
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935
Country
United States
Facility Name
TransitionTIL Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
TransitionTIL Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 3Z5
Country
Canada
Facility Name
TransitionTIL Investigational Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
TransitionTIL Investigational Site
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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