CompletedPhase 2

A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

Lead sponsor

Genentech, Inc.

Asset

Crenezumab

Listed sites

Recruiting sites

Enrollment

448

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 18-26

Primary endpoints

•ADAS-Cog•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

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

Secondary IDABBYGenentech

Org study IDABE4869g

Secondary IDGN00761Hoffmann-La Roche

NCT IDNCT01343966

Timeline

Milestones

Study first posted2011-04-28estimated

Study start2011-04-30actual

Primary completion2014-02-28actual

Study completion2014-02-28actual

Last update posted2017-07-12actual

Assets

Drug assets

Crenezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria

•Mini-Mental State Examination (MMSE) score of 18-26 points at screening

•Geriatric Depression Scale (GDS-15) score of < 6

•Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)

•If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization

Exclusion criteria

•Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care

•History or presence of clinically evident vascular disease potentially affecting the brain

•History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma

•Hospitalization within 4 weeks prior to screening

•Previous treatment with MABT5102A or any other therapeutic that targets Abeta

•Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

Endpoints (3)

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

Function / daily living

Global cognition

2 endpoints

Primary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score

Time frame:From baseline to Week 73

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score

Time frame:From baseline to Week 73

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score

Time frame:From baseline to Week 73

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Publications (2)

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.