Clinical trial NCT01028911: A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 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-03654746 in Mild to Moderate Alzheimer's Disease Patients on Stable Donepezil Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Phase 1 Alzheimer's disease Safety Tolerability Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 9
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: This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in subjects will mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Probable Alzheimer's disease
* Mini Mental State Examination score 18-26 inclusive
* Aged 55-85

Exclusion Criteria:

* Dementia other than Alzheimer's disease
* Clinically significant cardiovascular disease in the past 6 months prior to screening
* Creatinine clearance \<30 mL/min

Primary outcomes:
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Baseline up to 7 to 10 days after last dose
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to 7 to 10 days after last dose
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: Baseline up to 7 to 10 days after last dose
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examination
timeFrame: Baseline up to 7 to 10 days after last dose
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline
timeFrame: Baseline
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5
timeFrame: Day 5
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10
timeFrame: Day 10
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15
timeFrame: Day 15
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20
timeFrame: Day 20
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25
timeFrame: Day 25
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 30
timeFrame: Day 30
measure: Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Follow-up
timeFrame: Follow-up (7 to 10 days after last dose)
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 5
timeFrame: Baseline, Day 5
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 10
timeFrame: Baseline, Day 10
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 20
timeFrame: Baseline, Day 20
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 25
timeFrame: Baseline, Day 25
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 30
timeFrame: Baseline, Day 30
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Follow-up
timeFrame: Baseline, Follow-up (7 to 10 days after last dose)
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 5
timeFrame: Baseline, Day 5
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 10
timeFrame: Baseline, Day 10
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 20
timeFrame: Baseline, Day 20
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 25
timeFrame: Baseline, Day 25
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 30
timeFrame: Baseline, Day 30
measure: Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Follow-up
timeFrame: Baseline, Follow-up (7 to 10 days after last dose)
Secondary outcomes:
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-03654746
timeFrame: 0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30
measure: Maximum Serum Concentration (Cmax) for PF-03654746
timeFrame: 0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) for PF-03654746
timeFrame: 0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Donepezil
timeFrame: 0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30
measure: Maximum Plasma Concentration (Cmax) for Donepezil
timeFrame: 0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Donepezil
timeFrame: 0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: