Phase 2
N=191
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00930059 ↗Enrolled (actual)
191
Serious AEs
3.7%
Results posted
Nov 2020
Primary outcome: Primary: Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline — 21.87; 22.66 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04447943 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline |
21.87; 22.66 | — |
| PRIMARY Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12 |
-1.60; -1.91 | 0.3353 |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9 |
-1.36; -1.16; -1.17; -1.53; -2.05; -2.68 | 0.6073 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
3.64; 3.70; 3.51; 3.58; 3.63; 3.45 | 0.6547 |
| SECONDARY Neuropsychiatric Inventory (NPI) Total Score at Baseline |
12.16; 10.67 | — |
| SECONDARY Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12 |
-2.02; -1.33; -2.61; -1.76; -3.44; -2.49 | 0.7634 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00930059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.