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Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

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

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring mild to moderate Alzheimer's disease, memory, cognition, dementia

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has mild to moderate Alzheimer's disease
  • Patient has been receiving a stable dose of an acetylcholinesterase inhibitor
  • Patient has a MMSE score between 12 and 26
  • Patient has a MHIS score of less than or equal to 4
  • Females must be postmenopausal for at least two years or surgically sterile
  • Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit

Exclusion Criteria:

  • Patient is living in a nursing home
  • Patient has a history of any significant neurologic disease other than Alzheimer's disease
  • Patient has any uncontrolled medical illness
  • Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

D

E

F

G

Arm Description

Outcomes

Primary Outcome Measures

Safety and Tolerability

Secondary Outcome Measures

Pharmacokinetics (how the body handles the study drug)
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)

Full Information

First Posted
November 7, 2007
Last Updated
August 19, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00555204
Brief Title
Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Study Start Date
November 2007 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for 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
Keywords
mild to moderate Alzheimer's disease, memory, cognition, dementia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Experimental
Arm Title
E
Arm Type
Experimental
Arm Title
F
Arm Type
Experimental
Arm Title
G
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
10 mg - capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
5 mg - capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
15 mg - capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
20 mg - capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
30 mg - capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
35 mg - capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo - capsules once daily for 12 weeks
Primary Outcome Measure Information:
Title
Safety and Tolerability
Time Frame
Baseline to Final Evaluation
Secondary Outcome Measure Information:
Title
Pharmacokinetics (how the body handles the study drug)
Time Frame
Baseline to Final Evaluation
Title
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)
Time Frame
Baseline to Final Evaluation

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: Patient has mild to moderate Alzheimer's disease Patient has been receiving a stable dose of an acetylcholinesterase inhibitor Patient has a MMSE score between 12 and 26 Patient has a MHIS score of less than or equal to 4 Females must be postmenopausal for at least two years or surgically sterile Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit Exclusion Criteria: Patient is living in a nursing home Patient has a history of any significant neurologic disease other than Alzheimer's disease Patient has any uncontrolled medical illness Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lenz, MD, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
City
Hallendale
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
City
Nutley
State/Province
New Jersey
ZIP/Postal Code
07110
Country
United States
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10454
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25973909
Citation
Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease

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