Clinical trial NCT00988598: A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease
Official title: A PHASE 1, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR OPEN, RANDOMIZED, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-04447943 IN MILD TO MODERATE ALZHEIMER'S DISEASE SUBJECTS ON STABLE DONEPEZIL THERAPY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: phase 1 Alzheimer's disease donepezil
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety of PF-04447943 when given in combination with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the absorption and distribution of both PF-04447943 and donepezil.


Eligibility criteria: Inclusion Criteria:

* Subjects must have Alzheimer's dementia with a Mini Mental State Examination score between 18-26, inclusive.
* Subjects must have a reliable caregiver.
* Subjects must be on Aricept
* Memantine is allowed if subjects are on a stable dose
* Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG, with no serious or unstable disease within the past 3 months.

Exclusion Criteria:

* Subjects with clinically significant heart disease cannot participate.
* Subjects with a past or current history of seizures cannot participate.

Primary outcomes:
measure: Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern
timeFrame: Baseline up to Day 10
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern
timeFrame: Baseline up to Day 10
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to Day 10
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 10
Secondary outcomes:
measure: Plasma Concentrations of PF-04447943
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04447943
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04447943
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04447943
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
measure: Plasma Concentrations of Donepezil
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Donepezil
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
measure: Maximum Observed Plasma Concentration (Cmax) of Donepezil
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Donepezil
timeFrame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida - Center for Clinical Trials Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: