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A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

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NCT01066481

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Dementia, Dimebon, Investigational Drug
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

- Mild-to-Moderate Alzheimer's disease

- MMSE score 10-24 inclusive

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

- Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA
receptor antagonists within 90 days

- Complication of other causes of dementia

NCT01066481
Pfizer
Withdrawn
A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

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A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Dementia
  • Dimebon
  • Investigational Drug
  • Drug: PF-01913539 5 mg
    PF-01913539 5 mg three times daily for 6 months
  • Drug: Placebo
    Placebo three times daily for 6 months
  • Experimental: PF-01913539 5 mg three times daily
    PF-01913539 5 mg three times daily for 6 months
    Intervention: Drug: PF-01913539 5 mg
  • Experimental: PF-01913539 20 mg three times daily
    PF-01913539 20 mg three times daily for 6 months
    Intervention: Drug: PF-01913539 5 mg
  • Placebo Comparator: Placebo
    Placebo three times daily for 6 months
    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.
 
Withdrawn
0
April 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild-to-Moderate Alzheimer's disease
  • MMSE score 10-24 inclusive

Exclusion Criteria:

  • Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
  • Complication of other causes of dementia
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01066481
B1451010
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 2010

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.

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1-800-718-1021

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[email protected]



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