Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04447943 · 7 trials · 3 indications
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.
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.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Criteria for vital signs abnormalities of potential concern included: supine/standing systolic blood pressure (BP) (less than \[\<\] 90 millimeter of mercury \[mmHg\], maximum \[max\] decrease and increase of greater than or equal to \[\>=\] 30 mmHg from baseline); diastolic BP (\<50 mmHg, maximum decrease and increase of \>=20 mmHg from baseline); supine pulse rate \<40 beats per minute \[bpm\] or greater than \[\>\]120 bpm); standing pulse rate \<40 bpm or \>140 bpm. Baseline is defined as the last pre-dose (PF-04447943) recording at Day 0.
Criteria for ECG abnormalities of potential clinical concern included: PR interval (\>=300 milliseconds \[msec\], \>= 25 percent \[%\] increase when baseline \>200 msec or increase \>=50% when baseline less than or equal to \[\<=\] 200 msec); QRS interval (\>=200 msec, \>= 25% increase when baseline \>100 msec or increase \>=50% when baseline \<=100 msec); QT corrected using Fridericia's formula (QTcF) (\>=500 msec, maximum increase between \>=30 to \<60 msec and \>=60 msec). Baseline is defined as the last pre-dose (PF-04447943) recording at Day 0.
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (\<0.8\*lower limit of normal \[LLN\]); red blood cell count (\<0.8\*LLN); platelets (\<0.5\*LLN or \>1.75\* upper limit of normal \[ULN\]); leucocytes (\<0.6\*LLN or \>1.5\*ULN); lymphocytes, total neutrophils (\<0.8\*LLN or \>1.2\*ULN); basophils, eosinophils, monocytes (\>1.2\*ULN); total bilirubin (\>1.5\* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (\>3\*ULN); creatinine, blood urea nitrogen (\>1.3\*ULN); glucose (\<0.6\*LLN or \>1.5\*ULN); uric acid (\>1.2\*ULN); sodium (\<0.95\*LLN or 1.05\*ULN); potassium, calcium, chloride, bicarbonate (\<0.9\*LLN or 1.1\*ULN); albumin, total protein (\<0.8\*LLN or 1.2\*ULN); urine analysis. Total number of participants with any laboratory abnormalities was reported.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 after last dose that were absent before treatment or that worsened relative to pretreatment state. Any abnormalities related to physical and neurological findings, laboratory tests, vital signs and ECG were reported as adverse events. AEs included SAEs as well as non-serious AEs which occurred during the trial.
| Arm | Type | Description |
|---|---|---|
| PF-04447943 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| PF-04447943 low dose | EXPERIMENTAL | 25 mg of PF-04447943 |
| PF-04447943 high dose | EXPERIMENTAL | 100 mg of PF-04447943 |
| Moxifloxacin | ACTIVE_COMPARATOR | 400 mg of moxifloxacin |
| Active PF-04447943 | EXPERIMENTAL | - |
| Placebo PF-04447943 | PLACEBO_COMPARATOR | - |
| Single dose | EXPERIMENTAL | 3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects. |
| Multiple dose | EXPERIMENTAL | 3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects. |
| Sequence 1 | EXPERIMENTAL | - |
| Sequence 2 | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2). |
| Cohort 2 | EXPERIMENTAL | Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2). |
| Cohort 3a | EXPERIMENTAL | Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1). |
| Cohort 3b | EXPERIMENTAL | Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1). |
| Cohort 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04447943 | DRUG | tablets, 25 mg every 12 hours for 12 wks |
| Placebo | DRUG | matching placebo tablets, every 12 hours for 12 wks |
| Moxifloxacin | DRUG | Single oral dose of moxifloxacin administered as tablet |
| PF-04447943 25 mg | DRUG | 25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3) |
| Placebo PF | DRUG | Placebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3) |
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 week...
Top 20 of 24 competitors
PF-04447943 is an investigational small molecule being developed by Pfizer for Alzheimer's Disease. It has been studied in healthy volunteers as well. The drug is in Phase 2 clinical development, though all five completed trials to date were Phase 1 studies.
PF-04447943 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company has sponsored five clinical trials of the drug, all of which are now completed.
PF-04447943 is in Phase 2 clinical development for Alzheimer's Disease. However, all five completed trials listed for the drug were Phase 1 studies. It remains an investigational agent and is not FDA approved.
PF-04447943 has been studied in five completed trials, including NCT00832052 in healthy elderly participants, NCT00886093 examining food effects, NCT01097876 with donepezil, and NCT02785770 evaluating QTc interval effects. All were Phase 1 studies.
PF-04447943 is the primary name used in clinical trial records. No alternative names have been associated with this compound in the available data.