NCT01005862

Brief Summary

The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2010

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

2.5 years

First QC Date

October 30, 2009

Last Update Submit

September 25, 2012

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease antibody leucine ABeta

Outcome Measures

Primary Outcomes (1)

  • Fractional Clearance rate of ABeta peptide in CSF

    36 hours

Secondary Outcomes (4)

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

    36 hours

  • PF-04360365 concentrations and ABETA concentrations in plasma and CSF

    36 hours

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

    36 hours

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

    6 months

Study Arms (2)

PF-04360365

EXPERIMENTAL
Biological: PF-04360365

Placebo

PLACEBO COMPARATOR

single dose administered intravenously

Drug: Placebo

Interventions

PF-04360365BIOLOGICAL

10 mg/kg, single dose administered intravenously

PF-04360365
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Stockholm, 141 86, Sweden

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ponezumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

March 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

SE(1)US(2)