Study Evaluating the Efficacy and Safety of Bapineuzumab in Alzheimer Disease Patients Who are Apolipoprotein Ee4 non-carriers.

• Conditions: Alzheimer's Disease; MedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-012748-17-AT
• Lead Sponsor: Janssen Alzheimer Immunotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-24
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1450

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 < 89 years.
DIAGNOSIS of probable Alzheimer’s Disease according to the 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 of 16-26, inclusive.
ROSEN Modified Hachinski Ischemic score =4.
LIVES at home with appropriate caregiver capable of accompanying the subject on all clinic visits or; lives independently in community dwelling and has 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.
SCREENING visit brain MRI scan consistent with the diagnosis of AD.
FLUENCY in local language and evidence of adequate premorbid intellectual functioning.
SUBJECT must have adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
RECEIVING stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to screening. Concurrent treatment with cholinesterase inhibitors and/or memantine is allowed if the following conditions are met: (a) subject is maintained on a stable dose regimen for at least 120 days prior to screening; (b) subject is free of any clinically significant side effects attributable to the drug; and (c) subject and caregiver agree that, barring unforeseen circumstances, they will continue the same regimen for the duration of the trial.
WILLING to undergo ApoE testing and agree to disclosure of ApoE4 status.
NON-carrier of ApoE4 allele according to genotyping at screening.
IN the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study, including all scheduled evaluations and required tests.
THE caregiver must be a reliable informant in the opinion of the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 309
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1022

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 systemic illness that 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified