CompletedPhase 1

Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

Lead sponsor

Pfizer

Asset

PF-04360365

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•AD symptomatic therapy: stable ≥3 months•Healthy volunteers

Primary endpoint

•Fractional Clearance rate of ABeta peptide in CSF

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 IDA9951011

NCT IDNCT01005862

Timeline

Milestones

Study first posted2009-11-02estimated

Study start2010-03 (month precision)

Primary completion2012-09actual (month precision)

Study completion2012-09actual (month precision)

Last update posted2012-09-26estimated

Assets

Drug assets

PF-04360365

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age21 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)

•For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)

•Mini-mental status exam score greater than or equal to 20

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

•On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment

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 (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

Amyloid biomarkers

Neuroimaging

Fluid / digital biomarkers

Amyloid biomarkers

3 endpoints

Primary/protocol endpoint

Fractional Clearance rate of ABeta peptide in CSF

Time frame:36 hours

descriptive

Secondary/protocol endpoint

Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion

Time frame:36 hours

ratio, descriptive

Secondary/protocol endpoint

PF-04360365 concentrations and ABETA concentrations in plasma and CSF

Time frame:36 hours

concentration, descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI

Time frame:6 months

event count, event

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration

Time frame:36 hours

ratio, 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.