Ensayo de fase III, multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, sobre la eficacia y la seguridad del bapineuzumab (AAB-001, ELN115727) en pacientes con enfermedad de Alzheimer de grado leve a moderado que no son portadores de la apolipoproteína E (ApoE) e4 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-carriers

INTERVENTION: Product Name: AAB‐001 Pharmaceutical Form: Solution for injection INN or Proposed INN: Bapineuzumab CAS Number: n/a Current Sponsor code: AAB‐001, WAY 203740 Other descriptive name: anti‐Abeta Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Enfermedad de Alzheimer Alzheimer Disease ; MedDRA version: 9.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type PRIMARY OUTCOME: 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). Primary end point(s): ADAS‐Cog and DAD. 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. 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 <89 years. 3) Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke‐Alzheimer’s Disease and Related Disorders Association (NINCDS‐ADRDA) criteria. 4) MMSE score of 16 to 26, inclusive. 5) Rosen Modified Hachinski Ischemic Score =4. 6) Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study. 7) Screening visit brain MRI scan consistent with the diag