Back to resultsA Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
PF-04360365 10 mg/kg
PF-04360365 7.5 mg/kg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease amyloid imaging antibody
Eligibility Criteria
Inclusion Criteria:
- Males or females of non childbearing potential, age > or = 50.
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).
- 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
PF-04360365 10 mg/kg
PF-04360365 7.5 mg/kg
placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety/tolerability/PK of multiple doses of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 1 year (adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments)
Brain amyloid burden
CSF abeta
Secondary Outcome Measures
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma abeta, CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; immunogenicity (anti-drug antibodies)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00945672
Brief Title
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
Official Title
A Phase 2 Double-Blinded, Randomized, Placebo-Controlled, Multicenter Study Evaluating The Safety, Tolerability And Pharmacokinetics/ Pharmacodynamics Of PF-04360365 In Mild To Moderate Alzheimer's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease amyloid imaging antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04360365 10 mg/kg
Arm Type
Experimental
Arm Title
PF-04360365 7.5 mg/kg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
PF-04360365 10 mg/kg
Intervention Description
10 mg/kg every 90 days (5 total doses)
Intervention Type
Biological
Intervention Name(s)
PF-04360365 7.5 mg/kg
Intervention Description
10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo administered every 90 days or monthly to match experimental treatment arms.
Primary Outcome Measure Information:
Title
Safety/tolerability/PK of multiple doses of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 1 year (adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments)
Time Frame
18 months
Title
Brain amyloid burden
Time Frame
13 months
Title
CSF abeta
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma abeta, CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; immunogenicity (anti-drug antibodies)
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females of non childbearing potential, age > or = 50.
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
ZIP/Postal Code
431 41
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9951007&StudyName=A%20Multiple%20Dose%20Study%20of%20PF-04360365%20In%20Patients%20With%20Mild%20to%20Moderate%20Alzheimer%27s%20Disease
Description
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Learn more about this trial
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
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