Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
- Registration Number
- NCT01018875
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and ECG
- Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1, Dose 1, ABT-288 ABT-288 Low Dose Arm 2, Dose 2, ABT-288 ABT-288 High dose donepezil donepezil - sugar pill placebo -
- Primary Outcome Measures
Name Time Method ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
- Secondary Outcome Measures
Name Time Method MMSE: Mini Mental Status Exam Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD NPI: Neuropsychiatric Inventory Day -1, Weeks 4,8, 12/PD CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus Day -1, Weeks 4,8 & 12/PD] ADCS-ADL: Alzheimer's Disease Cooperative Study Day -1, Weeks 4,8 & 12/PD
Trial Locations
- Locations (21)
Site Reference ID/Investigator# 24565
🇺🇦Kherson, Ukraine
Site Reference ID/Investigator# 22636
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 22635
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 22633
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 23702
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 22634
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 22627
🇺🇦Poltava, Ukraine
Site Reference ID/Investigator# 22637
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 24563
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 22687
🇷🇺Kazan, Russian Federation
Site Reference ID/Investigator# 22632
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 22625
🇺🇦Donetsk, Ukraine
Site Reference ID/Investigator# 22622
🇺🇦Kiev, Ukraine
Site Reference ID/Investigator# 22623
🇺🇦Kiev, Ukraine
Site Reference ID/Investigator# 22630
🇺🇦Dnipropetrovs'k, Ukraine
Site Reference ID/Investigator# 22624
🇺🇦Glevakha, Ukraine
Site Reference ID/Investigator# 22629
🇺🇦Kharkiv, Ukraine
Site Reference ID/Investigator# 22628
🇺🇦Lugansk, Ukraine
Site Reference ID/Investigator# 22689
🇷🇺Saratov, Russian Federation
Site Reference ID/Investigator# 24566
🇺🇦Kiev, Ukraine
Site Reference ID/Investigator# 43143
🇺🇦Odessa, Ukraine