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PF-04447943

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Pfizer, Inc.|Trials Updated: Nov 19, 2020

PF-04447943 development status

Highest phase Phase 2
Registered trials 7 across 1 sponsor since Aug 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment206

FDA Designations

No designations recorded

PF-04447943 clinical trials

PF-04447943 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00930059A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED191 Analytics
PHASE2COMPLETED
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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.

Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern
Baseline up to Day 10

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.

Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern
Baseline up to Day 10

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.

Number of Participants With Laboratory Test Abnormalities
Baseline up to Day 10

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.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to Day 10

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.

Secondary Endpoints

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
Clinical Global Impression - Improvement (CGI-I)
Week 3, 6, 9, 12
Neuropsychiatric Inventory (NPI) Total Score at Baseline
Baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-04447943EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04447943DRUGtablets, 25 mg every 12 hours for 12 wks
PlaceboDRUGmatching placebo tablets, every 12 hours for 12 wks
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Eligibility Criteria

Age Range55 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites44

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...

Countries:United StatesCanadaChileCzechia
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Frequently asked questions about PF-04447943

What is PF-04447943?

PF-04447943 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for Alzheimer's disease. It was studied as an oral treatment for people with mild to moderate Alzheimer's disease. It is not an approved therapy and remains an experimental clinical-stage compound.

What is PF-04447943 used for in Alzheimer's disease?

PF-04447943 was studied for the treatment of mild to moderate Alzheimer's disease. Both of its clinical trials enrolled adults aged 55 years and older with that diagnosis. The program is no longer active, and PF-04447943 is not an approved treatment for Alzheimer's disease.

Who makes PF-04447943?

PF-04447943 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both clinical trials of the compound. No other developer or partner is associated with the program.

What phase is PF-04447943 in?

PF-04447943 reached Phase 2 clinical development. Its Phase 2 trial, NCT00930059, has completed, and an earlier Phase 1 study, NCT00988598, also completed. No trials are currently active, and the compound is not approved by the FDA.

What clinical trials is PF-04447943 in?

PF-04447943 was evaluated in two completed trials. NCT00930059 was a Phase 2, randomized, double-blind, placebo-controlled study of 191 participants with mild to moderate Alzheimer's disease across the United States, Canada, Chile, and Czechia. NCT00988598 was a Phase 1 study of 15 participants in the United States testing multiple doses with donepezil.