NCT01125631

Brief Summary

The purpose of the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese patients with mild-to-moderate Alzheimer's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

4 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

May 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 12, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

May 17, 2010

Last Update Submit

August 11, 2011

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseamyloidantibodyJapanese

Outcome Measures

Primary Outcomes (2)

  • Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)

    12 months

  • Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)

    12 months

Secondary Outcomes (1)

  • Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.

    12 months

Study Arms (2)

PF-04360365 8.5 mg/kg

EXPERIMENTAL
Biological: PF-04360365 8.5 mg/kg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04360365 8.5 mg/kgBIOLOGICAL

8.5 mg/kg every 8 weeks (4 doses total)

PF-04360365 8.5 mg/kg
PlaceboDRUG

Placebo every 8 weeks (4 doses total)

Placebo

Eligibility Criteria

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

You may qualify if:

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

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 (4)

Pfizer Investigational Site

Hirosaki, Aomori, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Fukuyama, Hiroshima, Japan

Location

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 12, 2011

Record last verified: 2011-08

Locations

JP(4)