NCT00455000

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2007

Typical duration for phase_1

Geographic Reach
4 countries

12 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

Study Start

First participant enrolled

March 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

2.5 years

First QC Date

March 29, 2007

Last Update Submit

October 12, 2009

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.

    366 days

Study Arms (2)

Active treatment

EXPERIMENTAL

5 possible active doses

Biological: PF-04360365

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04360365BIOLOGICAL

Monoclonal antibody

Active treatment
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Heidelberg West, Victoria, 3081, Australia

Location

Pfizer Investigational Site

Fremantle, Western Australia, 6160, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Pfizer Investigational Site

London, Ontario, N6A 4G5, Canada

Location

Pfizer Investigational Site

London, Ontario, N6C 5J1, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M3B 2W7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5V 2T3, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

Pfizer Investigational Site

Stockholm, 141 86, Sweden

Location

Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Pfizer Investigational Site

Southampton, SO30 3JB, United Kingdom

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

Study Record Dates

First Submitted

March 29, 2007

First Posted

April 2, 2007

Study Start

March 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

AU(3)CA(6)SE(1)GB(2)