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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012179-82 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04447943 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04447943 | Drug | tablets, 25 mg every 12 hours for 12 wks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline | 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. | Baseline (Day 1) |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Laboratory Test Abnormalities | Criteria for laboratory test abnormality: a) Hematology: white blood cells (WBC) <0.6*lower limit of normal (LLN)/>1.5*upper limit of normal (ULN), hemoglobin, hematocrit, red blood cells (RBC), lymphocytes <0.8*LLN, total neutrophils <0.8*LLN/ >1.2*ULN, basophils, eosinophils, monocytes >1.2*ULN; b) Liver Function: total bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT[>0.3*ULN, total protein, albumin <0.8*LLN/ >1.2*ULN; c) Renal Function: creatinine >1.3*ULN, uric acid >1.2*ULN; d) Electrolytes: sodium <0.95*LLN/ >1.05*ULN, potassium, chloride, bicarbonate <0.9*LLN/ >1.1*ULN; e) Clinical Chemistry: glucose <0.6*LLN/ >1.5*ULN, glycosylated hemoglobin >1.3*ULN; f) Urinalysis: ketones, protein, blood/hemoglobin, urine glucose >=1, RBC, WBC >=6, hyaline casts >1; g) Hormones: tetraiodothyronine (T4), triiodothyronine (T3) and thyroid stimulating hormone (TSH) <0.8*LLN/1.2*ULN.](streamdown:incomplete-link) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Clinic, PC | Northport | Alabama | 35476 | United States | ||
| ATP Clinical Research, Inc. |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks. |
| FG001 | PF-04447943 | PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
matching placebo tablets, every 12 hours for 12 wks |
|
| Baseline, Week 3, 6, 9 |
| Clinical Global Impression - Improvement (CGI-I) | 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. | Week 3, 6, 9, 12 |
| Neuropsychiatric Inventory (NPI) Total Score at 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. | Baseline |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 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. | Baseline, Week 3, 6, 9, 12 |
| Baseline up to Week 12 |
| Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities | Criteria for ECG (12-lead) abnormalities were as follow: 1) PR interval: greater than and equal to (>=) 300 milliseconds (msec), 2) PR interval: maximum increase from baseline >=25 percent (%) (if baseline PR interval greater than [>] 100 msec) or >=50% (if baseline PR interval less than or equal to [<=] 100 msec); 3) QRS complex: >=200 msec, 4) QRS complex: maximum increase from baseline >=25% or >=50%; 5) QT interval >=500 msec; 6) QT interval corrected using Bazett's formula (QTcB): 450 to less than (<) 480 msec, 7) QTcB: 480 to <500 msec, 8) QTcB: >=500 msec, 10) QTcB: 30 to <60 msec increase from baseline, 11) QTcB: >=60 msec increase from baseline; 9) QT interval corrected using the Fridericia's formula (QTcF): 450 to <480 msec, 10) QTcF: 480 to < 500 msec, 11) QTcF: >=500 msec, 12) QTcF: 30 to <60 msec increase from baseline, 13) QTcF: change>=60 msec increase from baseline. | Baseline up to Week 12 |
| Number of Participants With Abnormal Physical Examinations and Neurological Examinations | The complete physical and neurological examination included examination of abdomen, ears, extremities, eyes, general, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, pulse, skin, throat, thyroid, and others. Abnormality was judged by investigator. | Screening (28 days before Baseline), Week 12 |
| Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assessed whether participant experienced the following: suicidal behavior which includes suicide attempt, interrupted attempt, aborted attempt, and preparatory acts towards imminent suicidal behavior (response of "Yes" on "preparatory acts or behavior"); suicidal ideation (response of "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent); self-injurious behavior (SIB), intent unknown (response of "Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior?"). | Screening, Baseline, Post-baseline (Week 1 up to 12) |
| PF-04447943 Plasma Concentration | Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12 |
| Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities | Pre-defined criteria vital signs abnormalities included maximum increase or decrease of greater than or equal to (>=) 30 millimeters of mercury (mmHg) from baseline for supine systolic blood pressure (SBP); maximum increase or decrease of >=20 mmHg from baseline for supine diastolic BP (DBP); maximum increase or decrease of >=30 mmHg from baseline for standing SBP; maximum increase or decrease of >=20 mmHg from baseline for standing DBP. Orthostatic hypotension was defined as a drop of more than 10 mmHg in diastolic BP or a drop of more than 20 mmHg in systolic BP within 3 minutes of standing from the supine position. | Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Southwestern Research Incorporated | Glendale | California | 91204 | United States |
| Pacific Coast Imaging (for Imaging only) | Newport Beach | California | 92663 | United States |
| The Southwest Institute for Clinical Research, Inc. | Rancho Mirage | California | 92270 | United States |
| Pacific Research Network (Satellite Site) | San Diego | California | 92128 | United States |
| Pacific Research Network, Inc. (Satellite Site) | Vista | California | 92081 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Berma Research Group | Plantation | Florida | 33317 | United States |
| Joliet Center for Clinical Research | Joliet | Illinois | 60435 | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46805 | United States |
| Agewell | Indianapolis | Indiana | 46260 | United States |
| Four Rivers Clinical Research, Inc. | Paducah | Kentucky | 42003 | United States |
| Advanced MRI | Lake Charles | Louisiana | 70601 | United States |
| Lake Charles Clinical Trials, LLC | Lake Charles | Louisiana | 70601 | United States |
| Neurocare, Inc. | Newton | Massachusetts | 02459 | United States |
| Neurobehavioral Research Inc | Cedarhurst | New York | 11516 | United States |
| Behavioral Medical Research of Staten Island | Staten Island | New York | 10305 | United States |
| University of Pittsburgh Alzheimer's Disease Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center | Providence | Rhode Island | 02903 | United States |
| Neurology Clinic, PC | Cordova | Tennessee | 38018 | United States |
| Medical Arts Health Research Group | Kelowna | British Columbia | V1Y 3G8 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L9C 7N4 | Canada |
| Kawartha Regional Memory Clinic | Peterborough | Ontario | K9H 2P4 | Canada |
| Neuro Rive Sud Clinic | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Diex Recherche Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Psicomed Estudios Clinicos | Antofagasta | Antofagasta | Chile |
| Hospital Base Valdivia | Valdivia | Los Ríos Region | 5090145 | Chile |
| Centro Doctora Lissette Duque | Providencia | RM | 7500617 | Chile |
| Psicomedica Research Group | Santiago | RM | 7500710 | Chile |
| Hospital Del Salvador | Santiago | RM | 7500922 | Chile |
| Neuroconsult | Santiago | RM | 7550112 | Chile |
| Especialidades Medicas L y S | Santiago | RM | 7560356 | Chile |
| Neuropsicologia Ltda. | La Florida | Santiago Metropolitan | 8260094 | Chile |
| Fakultni nemocnice | Hradec Králové | 500 05 | Czechia |
| Pardubicka krajska nemocnice, a.s. | Pardubice | 53203 | Czechia |
| Pragtis, s.r.o. | Prague | 120 00 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 08 | Czechia |
| Psychiatry Trial, s.r.o. | Prague | 15800 | Czechia |
| Psychiatricka ambulance | Prague | 180 00 | Czechia |
| Neurologie - EEG, s.r.o | Prague | 18000 | Czechia |
| Centrum neurologicke pece, s.r.o. | Rychnov nad Kněžnou | 51601 | Czechia |
| Psychiatricka ambulance | Strakonice | 386 01 | Czechia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all participants who consumed at least 1 dose of randomized study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks. |
| BG001 | PF-04447943 | PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline | 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. | FAS included all participants who consumed at least 1 dose of randomized study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) |
|
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| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at 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. | FAS included all participants who consumed at least 1 dose of randomized study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 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. | FAS included all participants who consumed at least 1 dose of randomized study medication. "Number analyzed" signifies those participants who were evaluable for this measure at the specified time points for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 3, 6, 9 |
| ||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Improvement (CGI-I) | 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. | FAS included all participants who consumed at least 1 dose of randomized study medication. "Number Analyzed" signifies those participants who were evaluable for this measure at the specified time points for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 3, 6, 9, 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Neuropsychiatric Inventory (NPI) Total Score at 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. | FAS included all participants who consumed at least 1 dose of randomized study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| Secondary | Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 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. | FAS included all participants who consumed at least 1 dose of randomized study medication. "Number Analyzed" signifies those participants who were evaluable for this measure at the specified time points for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 3, 6, 9, 12 |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Laboratory Test Abnormalities | Criteria for laboratory test abnormality: a) Hematology: white blood cells (WBC) <0.6*lower limit of normal (LLN)/>1.5*upper limit of normal (ULN), hemoglobin, hematocrit, red blood cells (RBC), lymphocytes <0.8*LLN, total neutrophils <0.8*LLN/ >1.2*ULN, basophils, eosinophils, monocytes >1.2*ULN; b) Liver Function: total bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT[>0.3*ULN, total protein, albumin <0.8*LLN/ >1.2*ULN; c) Renal Function: creatinine >1.3*ULN, uric acid >1.2*ULN; d) Electrolytes: sodium <0.95*LLN/ >1.05*ULN, potassium, chloride, bicarbonate <0.9*LLN/ >1.1*ULN; e) Clinical Chemistry: glucose <0.6*LLN/ >1.5*ULN, glycosylated hemoglobin >1.3*ULN; f) Urinalysis: ketones, protein, blood/hemoglobin, urine glucose >=1, RBC, WBC >=6, hyaline casts >1; g) Hormones: tetraiodothyronine (T4), triiodothyronine (T3) and thyroid stimulating hormone (TSH) <0.8*LLN/1.2*ULN.](streamdown:incomplete-link) | Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to Week 12 |
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| Other Pre-specified | Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities | Criteria for ECG (12-lead) abnormalities were as follow: 1) PR interval: greater than and equal to (>=) 300 milliseconds (msec), 2) PR interval: maximum increase from baseline >=25 percent (%) (if baseline PR interval greater than [>] 100 msec) or >=50% (if baseline PR interval less than or equal to [<=] 100 msec); 3) QRS complex: >=200 msec, 4) QRS complex: maximum increase from baseline >=25% or >=50%; 5) QT interval >=500 msec; 6) QT interval corrected using Bazett's formula (QTcB): 450 to less than (<) 480 msec, 7) QTcB: 480 to <500 msec, 8) QTcB: >=500 msec, 10) QTcB: 30 to <60 msec increase from baseline, 11) QTcB: >=60 msec increase from baseline; 9) QT interval corrected using the Fridericia's formula (QTcF): 450 to <480 msec, 10) QTcF: 480 to < 500 msec, 11) QTcF: >=500 msec, 12) QTcF: 30 to <60 msec increase from baseline, 13) QTcF: change>=60 msec increase from baseline. | Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Number Analyzed" signifies those participants who were evaluable for specified rows for each arm, respectively. | Posted | Count of Participants | Participants | Baseline up to Week 12 |
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| Other Pre-specified | Number of Participants With Abnormal Physical Examinations and Neurological Examinations | The complete physical and neurological examination included examination of abdomen, ears, extremities, eyes, general, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, pulse, skin, throat, thyroid, and others. Abnormality was judged by investigator. | Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Number Analyzed" signifies those participants who were evaluable for specified rows for each arm, respectively. | Posted | Count of Participants | Participants | Screening (28 days before Baseline), Week 12 |
|
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| Other Pre-specified | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assessed whether participant experienced the following: suicidal behavior which includes suicide attempt, interrupted attempt, aborted attempt, and preparatory acts towards imminent suicidal behavior (response of "Yes" on "preparatory acts or behavior"); suicidal ideation (response of "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent); self-injurious behavior (SIB), intent unknown (response of "Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior?"). | Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Number Analyzed" signifies those participants who were evaluable for specified rows for each arm, respectively. | Posted | Count of Participants | Participants | Screening, Baseline, Post-baseline (Week 1 up to 12) |
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| Other Pre-specified | PF-04447943 Plasma Concentration | FAS included all the participants who consumed at least 1 dose of randomized study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this measure and "Number Analyzed" signifies those participants who were evaluable for this measure at the specified time points. | Posted | Median | Full Range | nanogram per milliliter | Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12 |
|
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| Other Pre-specified | Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities | Pre-defined criteria vital signs abnormalities included maximum increase or decrease of greater than or equal to (>=) 30 millimeters of mercury (mmHg) from baseline for supine systolic blood pressure (SBP); maximum increase or decrease of >=20 mmHg from baseline for supine diastolic BP (DBP); maximum increase or decrease of >=30 mmHg from baseline for standing SBP; maximum increase or decrease of >=20 mmHg from baseline for standing DBP. Orthostatic hypotension was defined as a drop of more than 10 mmHg in diastolic BP or a drop of more than 20 mmHg in systolic BP within 3 minutes of standing from the supine position. | Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. "Number Analyzed" signifies those participants who were evaluable for the specified rows for each arm, respectively. | Posted | Count of Participants | Participants | Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks. | 4 | 100 | 56 | 100 | ||
| EG001 | PF-04447943 | PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks. | 3 | 91 | 57 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Eyelid irritation | Eye disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dizziness | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Neuralgia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Right Knee Sore | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C572323 | 6-(4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl)-1-(tetrahydro-2H-pyran-4-yl)-1,5-dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one |
Not provided
Not provided
Not provided
| Male |
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| Units |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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