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CompletedPhase 2

Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

Assets

ABT-126 / Donepezil

Listed sites

33

Recruiting sites

-

Enrollment

438

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-24•Study partner/caregiver required

Primary endpoint

•Alzheimer's Disease Assessment Scale - cognitive subscale

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 number2011-002004-32
Org study IDM10-985
NCT IDNCT01527916

Timeline

Milestones

Study start2012-02 (month precision)
Study first posted2012-02-07estimated
Primary completion2013-11actual (month precision)
Study completion2013-11actual (month precision)
Last update posted2014-11-19estimated

Assets

Drug assets

ABT-126Donepezil

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

•The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
•The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
•The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
•The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
•The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
•The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
•With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
•The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study

Exclusion criteria

•The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
•The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
•The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
•In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
•The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.

Endpoints (10)

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

Behavior / neuropsychiatric
3
Caregiver / quality of life
2
Global cognition
1
Memory
1
Function / daily living
1
Other clinical outcomes
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Mini Mental Status Exam (MMSE)

Time frame:Measurements up through 24 weeks

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Memory

1 endpoint
Secondary/protocol endpoint

Wechsler Memory Scale-III (WMS-III) Working Memory Index

Time frame:Measurements up through 24 weeks

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

Time frame:Measurements up through 24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

3 endpoints
Secondary/protocol endpoint

Neuropsychiatry Inventory (NPI)

Time frame:Measurements up through 24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Partner-Patient Questionnaire for Shared Activities (PPQSA)

Time frame:Measurements up through 24 weeks

descriptive

Secondary/protocol endpoint

EuroQol-5D Questionnaires

Time frame:Measurements up through 24 weeks

descriptive

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

DEMentia Quality of Life (DEMQOL)

Time frame:Measurements up through 24 weeks

descriptive

Secondary/protocol endpoint

Resource Use in Dementia (RUD-Lite)

Time frame:Measurements up through 24 weeks

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Clinician Interview-Based Impression of Change - plus (CIBIC-plus)

Time frame:Measurements up through 24 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale - cognitive subscale

Time frame:Measurements up through 24 weeks

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

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.