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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00733642

Enrollment

Registered

2008-08-13

Start date

2008-08-31

Completion date

2009-07-31

Last updated

2009-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

antibody amyloid Alzheimer's Disease AD

Brief summary

The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.

Interventions

BIOLOGICALPF-04360365 1 mg/kg

PF-04360365 1 mg/kg infused as a single dose

BIOLOGICALPF-04360365 3 mg/kg

PF-04360365 3 mg/kg infused as a single dose

BIOLOGICALPF-04360365 5 mg/kg

PF-04360365 5 mg/kg infused as a single dose

BIOLOGICALPF-04360365 10 mg/kg

PF-04360365 10 mg/kg infused as a single dose

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.	6 months

Secondary

Measure	Time frame
To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.	6 months
To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026