Skip to main content
Delfa

← Trials/Trial dossier/NCT00948909

CompletedPhase 2

Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group 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

29

Recruiting sites

-

Enrollment

274

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24•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

Eudract number2009-011424-64
Org study IDM10-984
NCT IDNCT00948909

Timeline

Milestones

Study first posted2009-07-29estimated
Study start2009-10 (month precision)
Primary completion2010-11actual (month precision)
Study completion2010-11actual (month precision)
Last update posted2013-01-31estimated

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 is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
•The subject meets the NINCDS/ADRDA criteria for probable AD.
•The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
•The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
•If female, subject must be postmenopausal for at least two years or surgically sterile
•The subject has an identified, reliable, caregiver

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
•The subject has a history of any significant neurologic disease other than AD.
•In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
•The subject has reported history of discontinuation of donepezil due to lack of efficacy.
•The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
•The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
•Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
•Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).

Endpoints (2)

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.

Global cognition

2 endpoints
Primary/protocol endpoint

ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion

Time frame:Measurements up through 12 weeks.

ADAS-Cog

descriptive

Secondary/protocol endpoint

MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.

Time frame:Measurements up through 12 weeks.

ADAS-Cog

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.