Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bapineuzumab · 2 trials · 1 indication
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.
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: 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 dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.
Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.
Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to \[\>=\]160 millimeter mercury \[mm Hg\] or less than or equal to \[\<=\]90 mm Hg and increase or decrease of \>=20 mm Hg compared to baseline value), supine diastolic BP (\>=100 mm Hg or \<= 50 mm Hg and increase or decrease of \>=15 mm Hg compared to baseline value), supine pulse rate (\>=120 beats per minute (bpm) or \<=45 bpm and increase or decrease of \>15 bpm compared to baseline value), body temperature (\>38.3 degree Celsius and \<35 degree Celsius).
Criteria for determining PCI ECG result was described as: heart rate (\>=120 bpm or \<=45 bpm and increase or decrease of \>15 bpm compared to baseline value), PR interval (\>=220 millisecond (msec) and change of \>=20 msec compared to baseline value), QRS interval (\>=120 msec), corrected QT (QTc) interval for men (\>450 msec), QTc interval for women (\>470 msec).
Criteria for PCI laboratory results: hematology (hematocrit \[decrease \>=5%\], hemoglobin \[decrease \>=20gram/liter {g/L}\] from baseline, white blood cells \[\<3\], neutrophils \[\<1.5\], platelet \[\<100\], eosinophils \[\>0.5\] \*10\^9/L); blood chemistry (sodium \[\>5\], potassium \[\>0.5\], fasting glucose \[\>0.83\], phosphorous \[\>0.162\] millimole/L \[mmol/L\] above upper limit of normal \[ULN\] and below lower limit of normal \[LLN\], non-fasting glucose \>5 mmol/L above ULN, \>0.56 mmol/L below LLN, creatinine \>1.36\*ULN, blood urea nitrogen \>1.5\*ULN, calcium \[change of \>=0.25 mmol/L\], total protein \[change of \>=20g/L\], albumin \[change of \>=10g/L\], uric acid \[change of \>0.119mmol/L\] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase \[ALT/SGPT\] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase \[AST/SGOT\] \>2\*ULN, total bilirubin \>2\*ULN, alkaline phosphatase \>1.5\*ULN, gamma-glutamyl-transpeptidase \[GGT\] \>3\*ULN).
Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.
MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.
MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.
MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 5 mg/week |
| B | EXPERIMENTAL | 10 mg/week |
| C | EXPERIMENTAL | Placebo |
| 1 | EXPERIMENTAL | bapineuzumab 0.15 mg/kg or placebo |
| 2 | EXPERIMENTAL | bapineuzumab 0.5 mg/kg or placebo |
| 3 | EXPERIMENTAL | bapineuzumab 1.0 mg/kg or placebo |
| Name | Type | Description |
|---|---|---|
| bapineuzumab | DRUG | 5 mg bapineuzumab subcutaneous injection once per week for 6 months |
| placebo | DRUG | Placebo subcutaneous injection once per week for 6 months |
Inclusion Criteria: * Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria * Mini-Mental State Examination (MMSE) score 16-26 Exclusion Criteria: ...
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Bapineuzumab is an investigational monoclonal antibody that was studied for the treatment of Alzheimer Disease. It is not an approved therapy. Development reached Phase 2 clinical testing, and the program is no longer active, with all listed trials completed.
Bapineuzumab targets APP, the amyloid precursor protein. It is a monoclonal antibody designed as a binding agent directed at this target. By binding APP-related amyloid species, the antibody was intended to act on the amyloid pathway implicated in Alzheimer Disease.
Bapineuzumab was developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical studies of the antibody in Alzheimer Disease, including a Phase 2 trial conducted in the United States and a Phase 1 single ascending dose study conducted in Japan.
Bapineuzumab reached Phase 2 in clinical development for Alzheimer Disease. It is investigational and is not an approved medicine. The program has no active trials, and both listed studies, one Phase 2 and one Phase 1, are completed.
Bapineuzumab was studied in two completed trials. NCT00663026 was a Phase 2 study evaluating bapineuzumab in Alzheimer Disease subjects, enrolling 79 participants in the United States. NCT00397891 was a Phase 1 study of single ascending doses of AAB-001 in Japanese patients with Alzheimer Disease, enrolling 80 participants.
Yes, bapineuzumab is also known as AAB-001. The Phase 1 trial NCT00397891, which evaluated single ascending doses in Japanese patients with Alzheimer Disease, refers to the antibody by the AAB-001 name, while the Phase 2 trial NCT00663026 uses the bapineuzumab name.