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 e4 Non-carriers
- Conditions
- Alzheimer DiseaseMedDRA version: 9.1Level: PTClassification code 10012271Term: Dementia Alzheimer's type
- Registration Number
- EUCTR2007-005994-79-FR
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 885
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 diagnosis of AD.
8) Fluency in local language and evidence of adequate premorbid intellectual functioning.
9) Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
10) Receiving stable doses of medication(s) for the treatment of nonexcluded medical condition(s) for at least 30 days prior to screening, and, if treated with cholinesterase inhibitors and/or memantine, all of the following conditions are also met: (a) The subject is maintained on a stable dose regimen for at least 120 days prior to screening. (b) The subject is free of any clinically important side effects attributable to the drug. (c) The subject and caregiver agree that, barring unforeseen circumstances, they will continue the same regimen for the duration of the trial.
11) The subject and caregiver are likely to be able to participate in all scheduled evaluations and complete all required tests.
12) Willing to undergo apolipoprotein E (ApoE) testing and agree to disclosure of ApoE4 status.
13) Noncarrier of ApoE4 according to genotyping at screening (ie, has zero copies of ApoE4).
14) In the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method