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CompletedPhase 2

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

Assets

ABT-288 / Donepezil

Listed sites

21

Recruiting sites

-

Enrollment

242

actual

Study population

Alzheimer’s disease

Key I/E criteria

mild-to-moderate ADStudy 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

Eudract number2009-010704-29
Org study IDM10-822
NCT IDNCT01018875

Timeline

Milestones

Study first posted2009-11-24estimated
Study start2009-12 (month precision)
Primary completion2011-02actual (month precision)
Study completion2011-02actual (month precision)
Last update posted2018-06-06actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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
Function / daily living
1
Behavior / neuropsychiatric
1
Other clinical outcomes
1

Global cognition

2 endpoints
Primary/protocol endpoint

ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion

Time frame:Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD

ADAS-Cog

descriptive

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

ADCS-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 endpoint
Secondary/protocol endpoint

NPI: Neuropsychiatric Inventory

Time frame:Day -1, Weeks 4,8, 12/PD

Neuropsychiatric Inventory (NPI)

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

CIBIC-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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.