Enfermedad de Alzheimer Alzheimer Disease MedDRA version: 9.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed and dated written informed consent obtained from the subject or the subject’s legally acceptable representative (if applicable) in accordance with the local regulations. The subject’s caregiver must also consent to participate in the study. 2) Man or surgically sterile or postmenopausal woman, aged =50 to =65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1) Signed and dated written informed consent obtained from the subject or the subject’s legally acceptable representative (if applicable) in accordance with the local regulations. The subject’s caregiver must also consent to participate in the study. 2) Man or surgically sterile or postmenopausal woman, aged =50 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Significant neurologic disease, other than AD, that may affect cognition. 2) Screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages, evidence of a single prior hemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or space-occupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma). 3) Current presence of a clinically important major psychiatric disorder (eg, major depressive disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) or symptom (eg, hallucinations) that could affect the subject’s ability to complete the study. 4) Current clinically important systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study. 5) History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis or plaque. 6) History of seizures, excluding febrile seizures in childhood. 7) Weight greater than 120 kg (264 lb). 8) History or evidence of any clinically important autoimmune disease or disorder of the immune system (eg, Crohn disease, rheumatoid arthritis). 9) Clinically important infection within the last 30 days (eg, chronic persistent or acute infection, such as bronchitis or urinary tract infection [UTI]). 10) Treatment with immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years. 11) Myocardial infarction within the last 2 years. 12) History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin. 13) Uncontrolled hypertension within 6 months prior to screening. 14) Other clinically important abnormality on vital signs, physical examination, neurologic examination, laboratory results, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject. 15) Hemoglobin level less than 11 g/dL. ;Exclusion criteria: 1) Significant neurologic disease, other than AD, that may affect cognition. 2) Screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages, evidence of a single prior hemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or space-occupying lesions (eg, arachnoid cysts or brain tumors, such as meningioma). 3) Current presence of a clinically important major psychiatric disorder (eg, major depressive disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) or symptom (eg, hallucinations) that could affect the subject’s ability to complete the study. 4) Current clinically important systemic illness that is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study. 5) History of clinically evident stroke or history of clinically important carotid or vertebrobasilar stenosis or plaque. 6) History of seizures, excluding febrile seizures in childhood. 7) Weight greater than 120 kg (264 lb). 8) History or evidence of any clinically important autoimmune disease or disorder of the immune system (eg, Crohn disease, rheumatoid arthritis). 9) Clinically important infection within the last 30 days (eg, chronic persistent or acute infection, such as bronchitis or urinary tract infection [UTI]). 10) Treatment with immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years. 11) Myocardial infarction within the last 2 years. 12) History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin. 13) Uncontrolled hypertension within 6 months prior to screening. 14) Other clinically important abnormality on vital signs, physical examination, neurologic examination, laboratory results, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject. 15) Hemoglobin level less than 11 g/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate efficacy of multiple doses of intravenously (IV) administered bapineuzumab compared with placebo in subjects with mild to moderate AD as measured by change in scores from baseline to week 78 in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and the Disability Assessment for Dementia (DAD) (co-primary measures).;Secondary Objective: To investigate the safety and efficacy of multiple doses of intravenously (IV) administered bapineuzumab compared with placebo in subjects with mild to moderate AD as measured by change in scores from baseline to week 78 in the Neuropsychological Test Battery (NTB) and the Clinical Dementia Rating Sum of Boxes (CDR-SOB) (key secondary measures). Safety objectives include the incidence and severity of treatment-emergent adverse events (TEAEs), and clinically important changes in safety assessment results.;Primary end point(s): ADAS-Cog and DAD.;Main Objective: To investigate efficacy of multiple doses of intravenously (IV) administered bapineuzumab compared with placebo in subjects with mild to moderate AD as measured by change in scores from baseline to week 78 in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and the Disability Assessment for Dementia (DAD) (co-primary measures).;Secondary Objective: To investigate the safety and efficacy of multiple doses of intravenously (IV) administered bapineuzumab compared with placebo in subjects with mild to moderate AD as measured by change in scores from baseline to week 78 in the Neuropsychological Test Battery (NTB) and the Clinical Dementia Rating Sum of Boxes (CDR-SOB) (key secondary measures). Safety objectives include the incidence and severity of treatment-emergent adverse events (TEAEs), and clinically important changes in safety assessment results.;Primary end point(s): ADAS-Cog and DAD. | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed