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

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NCT01066481

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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

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Alzheimer's Disease, Dementia, Dimebon, Investigational DrugA Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
NCT01066481
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Dementia
  • Dimebon
  • Investigational Drug
Intervention  ICMJE
  • Drug: PF-01913539 5 mg
    PF-01913539 5 mg three times daily for 6 months
  • Drug: Placebo
    Placebo three times daily for 6 months
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 28, 2010)		0
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2010)		651
Estimated Study Completion Date  ICMJE April 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01066481
Other Study ID Numbers  ICMJE B1451010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP