Alzheimer's Disease MedDRA version: 14.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Bapineuzumab
Product Code: AAB-001
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bapineuzumab
CAS Number: N/A
Current Sponsor code: AAB-001
Other descri
Sponsors
Janssen Alzheimer Immunotherapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. AGE from 50 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: HAS significant neurological disease, other than AD, that may affect cognition. HISTORY of or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages (2 or more), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more), or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (eg, arachnoid cysts or brain tumors such as meningioma). NOTE: the MRI scan shall be interpreted by a local radiologist and a central radiologist prior to enrolling the subject. Both local and central interpretations shall be reviewed by the investigator for determination of subject eligibility. CURRENT presence of a clinically significant major psychiatric disorder (eg, Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) or symptom (eg, hallucinations) that could affect the subject’s ability to complete the study. CURRENT clinically significant chronic illness which is likely to result in deterioration of the subject’s condition or affect the subject’s safety during the study. HISTORY of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque. HISTORY of seizures, excluding febrile seizures in childhood. WEIGHT greater than 120kg (264lbs). HISTORY or evidence of any clinically significant autoimmune disease or disorder of the immune system (eg, Crohn’s Disease, Rheumatoid Arthritis). CLINICALLY significant infection within the last 30 days eg, chronic persistent or acute infection (eg, upper respiratory infection, urinary tract infection). 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. MYOCARDIAL infarction within the last 2 years. HISTORY of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin. UNCONTROLLED hypertension within the last 6 months. OTHER clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination that could compromise the study or be detrimental to the subject. HEMOGLOBIN less than 11g/dL. SUBJECTS who have donated blood (routine blood donation) in the 30 days prior to screening. EXCESSIVE smoking defined as >20 cigarettes per day. HISTORY of alcohol or drug dependence or abuse as defined by DSM-IV criteria within the last 2 years. CURRENT use of anticonvulsant drugs for seizures, antiparkinson drugs, anticoagulant medications (except the use of aspirin 325 mg/day or less, plavix, and persantine but not for stroke), or opioid pain relievers and related synthetic derivatives. CURRENT use of prescription or nonprescription medication for cognitive enhancement, other than cholinesterase inhibitors and memantine as previously described. HAS discontinued cholinesterase inhibitors, memantine, or cognitive enhancing agents within 60 days prior to screening, or drugs that potentially affect cognition in the 30 days prior to screening (including but not limited to anxiolytics, sedatives, hypnotics, antipsychotics, herbal preparation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary efficacy objective: To demonstrate the efficacy of multiple doses of IV-administered bapineuzumab (bapineuzumab IV; 0.5- and 1.0-mg/kg) compared to placebo in subjects with mild to moderate AD. Co-Primary Endpoints: The change from baseline to Week 78 in the Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog/11) total score The change from baseline to Week 78 in the Disability Assessment Scale for Dementia (DAD) total score Safety Objective and Endpoints: To assess the safety of multiple doses of bapineuzumab IV compared to placebo in subjects with mild to moderate AD. ? The incidence and severity of treatment-emergent adverse events (TEAEs) ? Clinically important changes in safety assessment results (including, as appropriate, brain magnetic resonance imaging [MRIs], vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], and physical and neurological examinations).;Secondary Objective: To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on time to first clinically meaningful deterioration in subjects with mild to moderate AD. To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on subject dependence in subjects with mild to moderate AD. To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on biomarkers that are indicative of disease pathophysiology in substudies of subjects with mild to moderate AD. To demonstrate divergence of effect (increasing separation with time compared with placebo) observed with multiple doses of bapineuzumab IV, in subjects with mild to moderate AD. To demonstrate the effect of multiple doses of bapineuzumab IV compared to placebo on a global clinical assessment (Clinical Dementia Rating Sum of Boxes [CDR-SB]) in subjects with mild to moderate AD. ;Primary end point(s): ADAS-Cog and DAD | — |
Countries
Austria, Canada, Germany, United States
Contacts
Public ContactHead of Clinical Development
Janssen Alzheimer Immunotherapy Research &
Outcome results
None listed