A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
Phase 2
Completed
- Conditions
- Alzheimer Disease
- Interventions
- Drug: PF-04494700 - Low Dose ArmDrug: PF-04494700 - High Dose ArmDrug: Placebo Comparator
- Registration Number
- NCT00141661
- Lead Sponsor
- Pfizer
- Brief Summary
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Arm PF-04494700 - Low Dose Arm - High Dose Arm PF-04494700 - High Dose Arm - Placebo Control Placebo Comparator -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Memphis, Tennessee, United States