← Trials/Trial dossier/NCT00733642

CompletedPhase 1

Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects 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 criteria

•Alzheimer's disease•MMSE 16-26•AD symptomatic therapy: stable

Primary endpoint

•Safety and tolerability of a single dose of PF-04360365

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 IDA9951008

NCT IDNCT00733642

Timeline

Milestones

Study start2008-08 (month precision)

Study first posted2008-08-13estimated

Primary completion2009-07actual (month precision)

Study completion2009-07actual (month precision)

Last update posted2009-07-28estimated

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

•Male or female (of non-child bearing potential) subjects ages ≥50 years of age.

•Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.

•MMSE score of 16-26 inclusive.

•Rosen-Modified Hachinski Ischemia Score ≤4.

•On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing

Exclusion criteria

•Diagnosis or history of other dementia 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.

•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

Other (unclassified)

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.

Time frame:6 months

descriptive

Secondary/protocol endpoint

To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.

Time frame:6 months

ratio, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.

Time frame:6 months

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.