A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

Phase 2

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Placebo
Drug: PF-04447943

Registration Number: NCT00930059

Lead Sponsor: Pfizer

Brief Summary: The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 191

Inclusion Criteria

Mild to moderate Alzheimer's disease (MMSE 14-26)
Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion Criteria

Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
Significant cardiovascular disease in the past 6 months
Illness other than Alzheimer's disease that could contribute to cognitive impairment
History of stroke or seizure disorder

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF-04447943	PF-04447943	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12	Baseline, Week 12	ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline	Baseline (Day 1)	ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12	Baseline, Week 3, 6, 9, 12	NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Clinical Global Impression - Improvement (CGI-I)	Week 3, 6, 9, 12	CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9	Baseline, Week 3, 6, 9	ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Neuropsychiatric Inventory (NPI) Total Score at Baseline	Baseline	NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.

Trial Locations

Locations (42): Neurology Clinic, PC
🇺🇸
Cordova, Tennessee, United States
ATP Clinical Research, Inc.
🇺🇸
Costa Mesa, California, United States
Southwestern Research Incorporated
🇺🇸
Glendale, California, United States
Pacific Coast Imaging (for Imaging only)
🇺🇸
Newport Beach, California, United States
The Southwest Institute for Clinical Research, Inc.
🇺🇸
Rancho Mirage, California, United States
Pacific Research Network (Satellite Site)
🇺🇸
San Diego, California, United States
Pacific Research Network, Inc. (Satellite Site)
🇺🇸
Vista, California, United States
MD Clinical
🇺🇸
Hallandale Beach, Florida, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Berma Research Group
🇺🇸
Plantation, Florida, United States
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Neurology Clinic, PC
🇺🇸Cordova, Tennessee, United States