| November 7, 2007 |
| June 10, 2009 |
| November 2007 |
| June 2009 (final data collection date for primary outcome measure) |
| Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: Yes ] |
| Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ] |
| Complete list of historical versions of study NCT00555204 on ClinicalTrials.gov Archive Site |
- Pharmacokinetics (how the body handles the study drug) [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: No ]
- Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: No ]
|
- Pharmacokinetics (how the body handles the study drug) [ Time Frame: Baseline to Final Evaluation ]
- Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) [ Time Frame: Baseline to Final Evaluation ]
|
| |
| Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease |
| 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 |
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Alzheimer's Disease |
- Drug: ABT-089
- Drug: placebo
|
| |
| |
| |
| Terminated |
| 337 |
|
| June 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 55 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00555204 |
| Daniel Llano, MD, PhD, Associate Medical Director, Abbott |
| M06-876 |
| Abbott |
|
| Study Director: |
Daniel Llano, MD, PhD |
Abbott |
|
|
| Abbott |
| May 2009 |
