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A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

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NCT00141661

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Sun City, Arizona, 85351 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer 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

- Diagnosis of probably Alzheimer's disease for at least 1 year.

- Mini Mental State Exam (MMSE) score between 12-26 at screening.

- Participants must be receiving a cholinesterase inhibitor and/or memantine for at
least 4 months, and on a stable dose for at least 2 months.

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

- Current evidence of a neurological or psychiatric illness that could contribute to
dementia.

- Living alone.

- Poorly controlled high blood pressure.

NCT00141661
Pfizer
Completed
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

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A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700
A 10-week safety and tolerability study of a potential treatment for 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 Disease
  • Drug: PF-04494700 - Low Dose Arm
    30 mg loading dose for 6 days, followed by 10 mg daily
  • Drug: PF-04494700 - High Dose Arm
    60 mg loading dose for 6 days, followed by 20 mg daily
  • Drug: Placebo Comparator
    Matching placebo.
  • Experimental: Low Dose Arm
    Intervention: Drug: PF-04494700 - Low Dose Arm
  • Experimental: High Dose Arm
    Intervention: Drug: PF-04494700 - High Dose Arm
  • Placebo Comparator: Placebo Control
    Intervention: Drug: Placebo Comparator
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
June 2006
June 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probably Alzheimer's disease for at least 1 year.
  • Mini Mental State Exam (MMSE) score between 12-26 at screening.
  • Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.

Exclusion Criteria:

  • Current evidence of a neurological or psychiatric illness that could contribute to dementia.
  • Living alone.
  • Poorly controlled high blood pressure.
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
 
 
NCT00141661
B0341008
TTP488-201
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Trans Tech Pharmaceuticals
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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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