CompletedPhase 1

Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

A Phase 1, Randomized, Placebo-Controlled, Double Blind, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

PF-04360365

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Safety of PF-04360365 in Japanese subjects•Pharmacokinetics of PF-04360365 following administration of multiple doses

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

Org study IDA9951016

NCT IDNCT01125631

Timeline

Milestones

Study start2010-05 (month precision)

Study first posted2010-05-18estimated

Primary completion2011-08actual (month precision)

Study completion2011-08actual (month precision)

Last update posted2011-08-12estimated

Assets

Drug assets

PF-04360365

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Japanese males or females of non childbearing potential, age > or = 50

•Diagnosis of probable Alzheimer's disease, consistent with criterial from both:

-National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)

-Diagnostic and Statistical Manual of Mental Disorders (DSM IV)

•Mini-mental status exam score of 16-26 inclusive

•Rosen-Modified Hachinski Ischemia Score of < or = 4

Exclusion criteria

•Diagnosis or history of other demential or neurodegenerative disorders

•Diagnosis or history of clinically significant cerebrovascular disease

•Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities

•History of autoimmune disorders

•History of allergic or anaphylactic reactions

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

Safety / tolerability / PK

Neuroimaging

1 endpoint

Primary/protocol endpoint

Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)

Time frame:12 months

event count, event

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)

Time frame:12 months

concentration, descriptive

Secondary/protocol endpoint

Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.

Time frame:12 months

concentration, descriptive

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.