Clinical trial NCT00809510: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 63
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
timeFrame: Month 1, 2, 4, 6
Secondary outcomes:
measure: ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
timeFrame: Month 1, 2, 4, 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 16543
state: Arizona
city: Sun City
country: United States
facility: Site Reference ID/Investigator# 16528
state: Arizona
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 16524
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 16520
state: California
city: Santa Monica
country: United States
facility: Site Reference ID/Investigator# 16521
state: California
city: Hamden
country: United States
facility: Site Reference ID/Investigator# 16533
state: Connecticut
city: Brooksville
country: United States
facility: Site Reference ID/Investigator# 16516
state: Florida
city: Deerfield Beach
country: United States
facility: Site Reference ID/Investigator# 16510
state: Florida
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 16508
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 16515
state: Florida
city: Palm Beach Gardens
country: United States
facility: Site Reference ID/Investigator# 16545
state: Florida
city: Sunrise
country: United States
facility: Site Reference ID/Investigator# 16541
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 16542
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 16529
state: Florida
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 16526
state: Indiana
city: Eatontown
country: United States
facility: Site Reference ID/Investigator# 16527
state: New Jersey
city: Ridgewood
country: United States
facility: Site Reference ID/Investigator# 16523
state: New Jersey
city: New York
country: United States
facility: Site Reference ID/Investigator# 16532
state: New York
city: Winston Salem
country: United States
facility: Site Reference ID/Investigator# 16519
state: North Carolina
city: Centerville
country: United States
facility: Site Reference ID/Investigator# 16525
state: Ohio
city: Wichita Falls
country: United States
facility: Site Reference ID/Investigator# 16507
state: Texas
city: Bennington
country: United States
facility: Site Reference ID/Investigator# 16509
state: Vermont
Study officials:
affiliation: Abbott
name: Robert Lenz
role: STUDY_DIRECTOR
References: