NCT00141661

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2 alzheimer-disease

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

August 30, 2005

Last Update Submit

August 19, 2009

Conditions

Alzheimer Disease

Keywords

Interventional, Alzheimer, Safety and Tolerability

Outcome Measures

Primary Outcomes (4)

  • Safety Measures include Adverse Events

    Every Visit

  • Laboratory Tests

    Every Office Visit

  • 12-Lead Electrocardiogram

    Every Office Visit

  • 24-Hour 12-Lead Serial ECGs

    Baseline, Study End

Secondary Outcomes (3)

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

    Baseline, Visit 5, Study End

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

    Screening Visit, Baseline, Study End

  • Pharmacokinetic Profile

    Baseline and Every Office Visit

Study Arms (3)

Low Dose Arm

EXPERIMENTAL
Drug: PF-04494700 - Low Dose Arm

High Dose Arm

EXPERIMENTAL
Drug: PF-04494700 - High Dose Arm

Placebo Control

PLACEBO COMPARATOR
Drug: Placebo Comparator

Interventions

PF-04494700 - Low Dose ArmDRUG

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

Low Dose Arm
PF-04494700 - High Dose ArmDRUG

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

High Dose Arm
Placebo ComparatorDRUG

Matching placebo.

Placebo Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current evidence of a neurological or psychiatric illness that could contribute to dementia.
  • Living alone.
  • Poorly controlled high blood pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Sun City, Arizona, 85351, United States

Location

Pfizer Investigational Site

Fresno, California, 93720, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Francisco, California, 94118, United States

Location

Pfizer Investigational Site

Fort Lauderdale, Florida, 33321, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, 33912, United States

Location

Pfizer Investigational Site

Hallandale, Florida, 33009, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32216, United States

Location

Pfizer Investigational Site

Largo, Florida, 33773, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations

US(12)