Clinical trial NCT00555204: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: mild to moderate Alzheimer's disease, memory, cognition, dementia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-11-08
Enrollment: 337
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Baseline to Final Evaluation
Secondary outcomes:
measure: Pharmacokinetics (how the body handles the study drug)
timeFrame: Baseline to Final Evaluation
measure: Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)
timeFrame: Baseline to Final Evaluation
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Hallendale
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Paducah
country: United States
state: Kentucky
city: Pittsfield
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: Long Branch
country: United States
state: New Jersey
city: Nutley
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Hickory
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Centerville
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Jenkintown
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
Study officials:
affiliation: Abbott
name: Robert Lenz, MD, PhD
role: STUDY_DIRECTOR
References:
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.