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Completed

NCT Number: NCT00141661

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

A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04494700 - Low Dose Arm

Drug

30 mg loading dose for 6 days, followed by 10 mg daily

PF-04494700 - High Dose Arm

Drug

60 mg loading dose for 6 days, followed by 20 mg daily

placebo comparator

Drug

Matching placebo.

Primary outcomes

  1. Safety Measures include Adverse Events

    Time frame: Every Visit

  2. Laboratory Tests

    Time frame: Every Office Visit

  3. 12-Lead Electrocardiogram

    Time frame: Every Office Visit

  4. 24-Hour 12-Lead Serial ECGs

    Time frame: Baseline, Study End

Secondary outcomes

  1. Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta

    Time frame: Baseline, Visit 5, Study End

  2. Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL

    Time frame: Screening Visit, Baseline, Study End

  3. Pharmacokinetic Profile

    Time frame: Baseline and Every Office Visit

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Trans Tech Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
Aug 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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