ABT-288
DrugSubjects will take 4 capsules once daily for 12 weeks.
NCT Number: NCT01018875
Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.
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Notify Me55 year–90 year
All sexes
Interventional
Phase 2
Site Reference ID/Investigator# 22687, Kazan', Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1. 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 Exclusion Criteria: 1. 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.
Subjects will take 4 capsules once daily for 12 weeks.
Subjects will take 4 capsules once daily for 12 weeks.
Other names: Aricept
Subjects will take 4 capsules once daily for 12 weeks.
Time frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Time frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Time frame: Day -1, Weeks 4,8, 12/PD
Time frame: Day -1, Weeks 4,8 & 12/PD
Time frame: Day -1, Weeks 4,8 & 12/PD]
AbbVie (prior sponsor, Abbott)
Industry
A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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