Alzheimer's Disease
Conditions
Keywords
mild to moderate Alzheimer's disease, memory, cognition, dementia
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.
Interventions
DRUGABT-089
10 mg - capsules once daily for 12 weeks
DRUGplacebo
placebo - capsules once daily for 12 weeks
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | Baseline to Final Evaluation |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (how the body handles the study drug) | Baseline to Final Evaluation |
| Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) | Baseline to Final Evaluation |
Countries
United States
Outcome results
None listed