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Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
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
Lead sponsor
Assets
ABT-288 / Donepezil
Listed sites
21
Recruiting sites
-
Enrollment
242
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild-to-moderate AD•Study partner/caregiver required
Primary endpoint
•ADAS-Cog
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
Time frame:Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
ADAS-Cog
descriptive
MMSE: Mini Mental Status Exam
Time frame:Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Mini-Mental State Examination (MMSE)
categorical status, descriptive
Function / daily living
1 endpointADCS-ADL: Alzheimer's Disease Cooperative Study
Time frame:Day -1, Weeks 4,8 & 12/PD
ADCS-Activities of Daily Living (ADCS-ADL)
descriptive
Behavior / neuropsychiatric
1 endpointNPI: Neuropsychiatric Inventory
Time frame:Day -1, Weeks 4,8, 12/PD
Neuropsychiatric Inventory (NPI)
descriptive
Other clinical outcomes
1 endpointCIBIC-Plus: Clinician Interview-Baed Impression of Change - plus
Time frame:Day -1, Weeks 4,8 & 12/PD]
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID28720101via BACKGROUND
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.