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A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject was randomized into Study M06-876 and completed the study.
  • The subject must remain on the same dose of AChEI that was used during the M06-876 study.
  • The subject is in general good health, as judged by the investigator

Exclusion Criteria:

  • The subject is currently, or plans to participate in another experimental study during the course of this trial.
  • The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.

Sites / Locations

  • Site Reference ID/Investigator# 16543
  • Site Reference ID/Investigator# 16528
  • Site Reference ID/Investigator# 16524
  • Site Reference ID/Investigator# 16520
  • Site Reference ID/Investigator# 16521
  • Site Reference ID/Investigator# 16533
  • Site Reference ID/Investigator# 16516
  • Site Reference ID/Investigator# 16510
  • Site Reference ID/Investigator# 16508
  • Site Reference ID/Investigator# 16515
  • Site Reference ID/Investigator# 16545
  • Site Reference ID/Investigator# 16541
  • Site Reference ID/Investigator# 16542
  • Site Reference ID/Investigator# 16529
  • Site Reference ID/Investigator# 16526
  • Site Reference ID/Investigator# 16527
  • Site Reference ID/Investigator# 16523
  • Site Reference ID/Investigator# 16532
  • Site Reference ID/Investigator# 16519
  • Site Reference ID/Investigator# 16525
  • Site Reference ID/Investigator# 16507
  • Site Reference ID/Investigator# 16509

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)

Secondary Outcome Measures

ADAS-Cog, CIBIC-plus, MMSE, QoL-AD

Full Information

First Posted
December 15, 2008
Last Updated
September 1, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00809510
Brief Title
A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
20 mg ABT-089 taken once-daily for 6 months
Primary Outcome Measure Information:
Title
Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time Frame
Month 1, 2, 4, 6
Secondary Outcome Measure Information:
Title
ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
Time Frame
Month 1, 2, 4, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject was randomized into Study M06-876 and completed the study. The subject must remain on the same dose of AChEI that was used during the M06-876 study. The subject is in general good health, as judged by the investigator Exclusion Criteria: The subject is currently, or plans to participate in another experimental study during the course of this trial. The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lenz
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 16543
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Site Reference ID/Investigator# 16528
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Site Reference ID/Investigator# 16524
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Site Reference ID/Investigator# 16520
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Site Reference ID/Investigator# 16521
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Site Reference ID/Investigator# 16533
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Site Reference ID/Investigator# 16516
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Site Reference ID/Investigator# 16510
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Site Reference ID/Investigator# 16508
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Site Reference ID/Investigator# 16515
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Site Reference ID/Investigator# 16545
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Site Reference ID/Investigator# 16541
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Site Reference ID/Investigator# 16542
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Site Reference ID/Investigator# 16529
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Site Reference ID/Investigator# 16526
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Site Reference ID/Investigator# 16527
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Site Reference ID/Investigator# 16523
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Site Reference ID/Investigator# 16532
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site Reference ID/Investigator# 16519
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Reference ID/Investigator# 16525
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Site Reference ID/Investigator# 16507
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Site Reference ID/Investigator# 16509
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States

12. IPD Sharing Statement

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A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study

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