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A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85006 United States
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

- Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.

- Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at
least 4 months prior to randomization

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

- Current evidence or history of neurological, psychiatric and any other illness that
could contribute to non-Alzheimer's dementia.

- Known history of familial AD or any evidence for early onset AD known or possibly
associated with genetic mutations.

- Evidence or history of diabetes mellitus Type 1 or Type 2.

- History or symptoms of autoimmune disorders.

NCT00566397
Pfizer
Completed
A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

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1-800-718-1021

[email protected]

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A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease
A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: PF-04494700
    15 mg for 6 days followed by daily dosing of 5mg
  • Drug: PF-04494700
    60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: PF-04494700
  • Experimental: 2
    Intervention: Drug: PF-04494700
  • Placebo Comparator: 3
    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
402
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
  • Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization

Exclusion Criteria:

  • Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
  • Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
  • Evidence or history of diabetes mellitus Type 1 or Type 2.
  • History or symptoms of autoimmune disorders.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00566397
B0341002
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Alzheimer's Disease Cooperative Study (ADCS)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

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]



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