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| ID | Type | Description | Link |
|---|---|---|---|
| B2521008 |
Not provided
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The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 5 mg/week |
|
| B | Experimental | 10 mg/week |
|
| C | Experimental | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bapineuzumab | Drug | 5 mg bapineuzumab subcutaneous injection once per week for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to 30 days after Week 25 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 | |
| Average Serum Concentration at Steady State (Cavg,ss) |
Not provided
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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85006 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months. |
| FG001 | Bapineuzumab 5 mg | Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| bapineuzumab |
| Drug |
10 mg bapineuzumab subcutaneous injection once per week for 6 months |
|
| placebo | Drug | Placebo subcutaneous injection once per week for 6 months |
|
Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.
| Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
| Serum Decay Half-Life (t1/2) | Serum decay half-life is the time measured for the serum concentration to decrease by one half. | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week. | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
| Apparent Systemic Clearance (CL/F) | Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau. | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Pfizer Investigational Site | Encino | California | 91316 | United States |
| Pfizer Investigational Site | Los Alamitos | California | 90720 | United States |
| Pfizer Investigational Site | Newport Beach | California | 92660 | United States |
| Pfizer Investigational Site | Delray Beach | Florida | 33445 | United States |
| Pfizer Investigational Site | Hallandale | Florida | 33009 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67211 | United States |
| Pfizer Investigational Site | Rochester | New York | 14620 | United States |
| Pfizer Investigational Site | East Providence | Rhode Island | 02914 | United States |
| Pfizer Investigational Site | Providence | Rhode Island | 02906 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75214 | United States |
| Pfizer Investigational Site | Bennington | Vermont | 05201 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53705 | United States |
| FG002 | Bapineuzumab 10 mg | Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months. |
| BG001 | Bapineuzumab 5 mg | Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months. |
| BG002 | Bapineuzumab 10 mg | Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months. |
| BG003 | 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days after Week 25 dose |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) | Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]). | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Average Serum Concentration at Steady State (Cavg,ss) | Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week. | PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng/mL | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Serum Decay Half-Life (t1/2) | Serum decay half-life is the time measured for the serum concentration to decrease by one half. | t1/2 not calculated due to inadequate characterization of the terminal elimination phase. | Posted | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) | PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). | Posted | Median | Full Range | hours | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week. | PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | ng*hr/mL | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Apparent Systemic Clearance (CL/F) | Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau. | PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | milliliter/hour/kilogram (mL/hr/kg) | Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12 |
|
Not provided
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 subject and as nonserious in another subject, or one subject 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 bapineuzumab subcutaneous injection once weekly for 6 months. | 1 | 19 | 15 | 19 | ||
| EG001 | Bapineuzumab 5 mg | Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months. | 2 | 29 | 22 | 29 | ||
| EG002 | Bapineuzumab 10 mg | Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months. | 3 | 31 | 27 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Subdural hemorrhage | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Atypical fibroxanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v13.0 | Non-systematic Assessment |
|
Designation of outcomes as primary, secondary was based on study team's input as study did not specify them as primary or secondary.
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 |
|---|---|
| C545458 | bapineuzumab |
Not provided
Not provided
Not provided
| Male |
|
| Title | Measurements |
|---|---|
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| Units |
|---|
| Counts |
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