Alzheimer Disease MedDRA version: 14.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola road, Collegeville, PA 19426 USA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent obtained from the subject or the subject’s legal 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 860
Exclusion criteria
Exclusion criteria: 1) Significant neurologic disease, other than AD, that may affect cognition. 2) History of or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages (two or more), 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). NOTE : the screening MRI scan shall be interpreted by the local and central radiologists prior to enrolling the subject. Both local and central interpretations shall be reviewed by the investigator for determination of subject eligibility relative to inclusion criteria # 7 and exclusion criteria # 2. 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 or is a safety concern.. 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 the safety and efficacy of multiple doses of intravenously (IV) administered bapineuzumab at 0.5 mg/kg compared with placebo in subjects with mild to moderate AD as measured by: Primary: Change in total scores from baseline to week 78 in the Alzheimer’s Disease Assessment Scale– Cognitive Subscale 11-item score (ADAS-Cog/11) and the Disability Assessment for Dementia (DAD) (coprimary measures).;Secondary Objective: These Include: Biomarker Objective Divergence of effect Objective Clinical and Health Outcomes Objective Other Please refer to section 10.3 of Protocol;Primary end point(s): ADAS-Cog/11 total score and DAD.;Timepoint(s) of evaluation of this end point: Baseline and weeks 13, 26, 39, 52, 65, 78 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change from baseline to week 71 in brain amyloid burden (average standard uptake value ratio [SUVr] in prespecified regions of interest [ROIs]) assessed by PIB PET imaging in a subset of subjects; • The change from baseline to week 71 in phospho-tau levels in the CSF in a subset of subjects; • The change from baseline to week 71 in brain volume, assessed by MRI BBSI in a subset of subjects. • Divergence of effect on the ADAS-Cog/11 total scores from week 39 to week 78 between bapineuzumab and placebo; • Divergence of effect on the DAD total scores from week 39 to week 78 between bapineuzumab and placebo. • Time to median placebo deterioration on ADAS-Cog/11 total score • Time to median placebo deterioration on DAD • Change from baseline to Week 78 in the total Dependence Scale scores • Please refer to Section 10.3.2 of the Protocol for Other Secondary Objectives ;Timepoint(s) of evaluation of this end point: •PIB PET: Baseline, Weeks 45 and 71 • CSF: Baseline and week 71 • Volumetric MRI: Baseline, Weeks 6, 19, 32, 45, 58, and 71 • ADAS-Cog and DAD (for secondary endpoint): Weeks 39, 52, 65 and 78 • Time to median placebo deterioration on ADAS-Cog and DAD: Baseline and week 78 • Dependence scale: Baseline, Weeks 26, 52 and 78 | — |
Countries
Argentina, Australia, Austria, Belgium, Chile, Croatia, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed