A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

A Phase I, Randomized, Placebo Controlled, Double Blind Dose Escalation Study Of The Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00455000

Enrollment

Registered

2007-04-02

Start date

2007-03-31

Completion date

2009-09-30

Last updated

2009-10-14

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

Conditions

Alzheimer's Disease

Brief summary

The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.

Interventions

BIOLOGICALPF-04360365

Monoclonal antibody

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Male or Females of non-childbearing potential, age 50-85 * Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV) * Mini-mental status exam score of 16-26 inclusive * Rosen-Modified Hachinski Ischemia Score \< or = 4

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, extensive white matter abnormalities * History of autoimmune disorders * History of allergic or anaphylactic reactions

Design outcomes

Primary

Measure	Time frame
To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing.	366 days

Secondary

Measure	Time frame
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.	366 days

Countries

Australia, Canada, Sweden, United Kingdom

Outcome results

None listed

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