Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00722046

Purpose

Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.

Condition	Intervention	Phase
Alzheimer's Disease	Biological: PF-04360365 0.1 mg/kg Biological: PF-04360365 0.5 mg/kg Biological: PF-04360365 1 mg/kg Drug: Placebo Biological: PF-04360365 3 mg/kg Biological: PF-04360365 8.5 mg/kg	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Official Title:	A Phase 2 Multicenter, Randomized, Double Blind, Placebo-Controlled Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety/tolerability of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 18 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Pharmacokinetics of PF-04360365 following administration of multiple doses in subjects with mild to moderate Alzheimer's disease. (plasma and cerebrospinal fluid (as available) PF-04360365 concentrations) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma/CSF Abeta; CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; Immunogenicity (anti-drug antibodies) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-04360365 0.1 mg/kg: Experimental	Biological: PF-04360365 0.1 mg/kg 0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kg: Experimental	Biological: PF-04360365 0.5 mg/kg 0.5 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kg: Experimental	Biological: PF-04360365 1 mg/kg 1 mg/kg every 60 days (10 doses total)
Placebo: Placebo Comparator	Drug: Placebo Placebo every 60 days (10 doses total)
PF-04360365 3 mg/kg: Experimental	Biological: PF-04360365 3 mg/kg 3 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kg: Experimental	Biological: PF-04360365 8.5 mg/kg 8.5 mg/kg every 60 days (10 doses total)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722046

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 37 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9951002
Study First Received:	July 23, 2008
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00722046 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Alzheimer's disease
antibody
amyloid

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 20, 2009