A Phase 2 interventional study of bapineuzumab and bapineuzumab in Alzheimer Disease, sponsored by Pfizer. Completed at 17 sites in United States. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2013-11-15.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 79 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5 mg/week
Drug: bapineuzumab
10 mg/week
Drug: bapineuzumab
Placebo
Drug: placebo
5 mg bapineuzumab subcutaneous injection once per week for 6 months
10 mg bapineuzumab subcutaneous injection once per week for 6 months
Placebo subcutaneous injection once per week for 6 months
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.
Time frame: Baseline up to 30 days after Week 25 dose
Maximum Observed Serum Concentration (Cmax)
Time frame: 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)
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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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
| Milestone | Placebo | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|---|
| Started | 19 | 29 | 31 |
| Completed | 17 | 23 | 27 |
| Not completed | 2 | 6 | 4 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Other | 1 | 2 | 0 |
| Withdrew: Adverse event | 0 | 2 | 3 |
| Withdrew: Caregiver request | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
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.
| participants | Placebo | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|---|
| AEs | 16 | 22 | 28 |
| SAEs | 1 | 2 | 3 |
| nanogram per milliliter (ng/mL) | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | 4219.97 ± 945.23 | 8012.88 ± 2793.53 |
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.
| ng/mL | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|
| Average Serum Concentration at Steady State (Cavg,ss) | 3123.071 ± 1074.116 | 6912.301 ± 2149.143 |
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
No measurements were reported for this outcome.
| hours | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) | 3696.00 (1680.00 to 4368.00) | 4200.00 (72.00 to 4368.00) |
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.
| ng*hr/mL | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | 524675.88 ± 180451.56 | 1161266.63 ± 361056.04 |
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.
| milliliter/hour/kilogram (mL/hr/kg) | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|
| Apparent Systemic Clearance (CL/F) | 0.16 ± 0.05 | 0.132 ± 0.069 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/19 (5.3%) | 15/19 (78.9%) |
| Bapineuzumab 5 mg | — | 2/29 (6.9%) | 22/29 (75.9%) |
| Bapineuzumab 10 mg | — | 3/31 (9.7%) | 27/31 (87.1%) |
| Event | Placebo | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|---|
| Lobar pneumoniaInfections and infestations | 1/19 | 0/29 | 0/31 |
| Serum sicknessImmune system disorders | 0/19 | 1/29 | 0/31 |
| ConvulsionNervous system disorders | 0/19 | 1/29 | 0/31 |
| Atrial fibrillationCardiac disorders | 0/19 | 0/29 | 1/31 |
| Subdural hemorrhageInjury, poisoning and procedural complications | 0/19 | 0/29 | 1/31 |
| Subarachnoid hemorrhageNervous system disorders | 0/19 | 0/29 | 1/31 |
| DeliriumPsychiatric disorders | 0/19 | 0/29 | 1/31 |
| CystoceleReproductive system and breast disorders | 0/19 | 0/29 | 1/31 |
| RectoceleReproductive system and breast disorders | 0/19 | 0/29 | 1/31 |
| Event | Placebo | Bapineuzumab 5 mg | Bapineuzumab 10 mg |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/19 | 1/29 | 6/31 |
| Vasogenic cerebral oedemaNervous system disorders | 0/19 | 2/29 | 6/31 |
| DiarrhoeaGastrointestinal disorders | 2/19 | 5/29 | 2/31 |
| FatigueGeneral disorders | 2/19 | 2/29 | 0/31 |
| NasopharyngitisInfections and infestations | 2/19 | 1/29 | 0/31 |
| SinusitisInfections and infestations | 2/19 | 0/29 | 0/31 |
| Urinary tract infectionInfections and infestations | 2/19 | 1/29 | 1/31 |
| DizzinessNervous system disorders | 2/19 | 2/29 | 2/31 |
| HeadacheNervous system disorders | 2/19 | 2/29 | 2/31 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/19 | 0/29 | 0/31 |
| Age Continuous(years) | Placebo | Bapineuzumab 5 mg | Bapineuzumab 10 mg | Total |
|---|---|---|---|---|
| Mean | 76.16 ± 8.63 | 71.28 ± 8.73 | 72.42 ± 8.83 | 72.90 ± 8.85 |
| Sex: Female, Male(Participants) | Placebo | Bapineuzumab 5 mg | Bapineuzumab 10 mg | Total |
|---|---|---|---|---|
| Female | 8 | 18 | 12 | 38 |
| Male | 11 | 11 | 19 | 41 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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