Clinical trial NCT00141661: A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Interventional, Alzheimer, Safety and Tolerability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Trans Tech Pharmaceuticals
First posted: 2005-09-01
Enrollment: 67
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety Measures include Adverse Events
timeFrame: Every Visit
measure: Laboratory Tests
timeFrame: Every Office Visit
measure: 12-Lead Electrocardiogram
timeFrame: Every Office Visit
measure: 24-Hour 12-Lead Serial ECGs
timeFrame: Baseline, Study End
Secondary outcomes:
measure: Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta
timeFrame: Baseline, Visit 5, Study End
measure: Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL
timeFrame: Screening Visit, Baseline, Study End
measure: Pharmacokinetic Profile
timeFrame: Baseline and Every Office Visit
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Largo
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: