You are here

A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Göteborg, , 413 45 Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00945672
Pfizer
Completed
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
NCT03513588
All Genders
Hypercholesterolemia Coronary Artery Disease
NCT02565615
All Genders
18+
Years
Multiple Sites
Raynaud's Disease, Peripheral Vascular Disease
NCT01090492
All Genders
18+
Years
Multiple Sites
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: PF-04360365 10 mg/kg
    10 mg/kg every 90 days (5 total doses)
  • Biological: PF-04360365 7.5 mg/kg
    10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)
  • Drug: placebo
    placebo administered every 90 days or monthly to match experimental treatment arms.
  • Experimental: PF-04360365 10 mg/kg
    Intervention: Biological: PF-04360365 10 mg/kg
  • Experimental: PF-04360365 7.5 mg/kg
    Intervention: Biological: PF-04360365 7.5 mg/kg
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00945672
A9951007
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now