A Long-Term Safety and Tolerability Study of Bapineuzumab in Alzheimer Disease Patients Who Are Apolipoprotein E e4 Non-Carriers

• Conditions: Alzheimer 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: EUCTR2009-015079-29-DE
• Lead Sponsor: Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola road, Collegeville, PA 19426 USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-06
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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. Subject has completed all 6 infusions planned in protocol 3133K1-3000; or, if the subject was required to temporarily suspend investigational product (e.g., due to vasogenic edema, adverse event, study suspension), he/she continued with required visits, has completed all study visits through the week 78 visit and his/her current status indicates that he/she resumed or is eligible to resume investigational product.
NOTE: Subjects who developed vasogenic edema during study 3133K1-3000 may be considered for study 3133K1-3002 participation if the abnormality is resolved and the subject met criteria to resume investigational product. Sponsor clinician physician approval to resume investigational product infusions is required prior to enrollment.
3. Brain MRI scan from Week 71 of study 3133K1-3000 is available for local radiology and central radiology evaluation and remains consistent with the diagnosis of AD.
4. MMSE score =10 at screening (Week 78 of 3133K1-3000).
5. Continues to live at home or is community dwelling with appropriate caregiver capable of accompanying the subject on all clinic visits and visiting with the subject at least 5 days per week, on average for the duration of the study.
6. In the opinion of the principal investigator, the subject and the caregiver will be compliant, and likely to participate in all scheduled evaluations.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 790
;
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. Subject has completed all 6 infusions planned in protocol 3133K1-3000; or, if the subject was required to temporarily suspend investigational product (e.g., due to vasogenic edema, adverse event, study suspension), he/she continued with required visits, has completed all study visits through the week 78 visit and his/her current status indicates that he/she resumed or is eligible to resume investigational product.
NOTE: Subjects who developed vasogenic edema during study 3133K1-3000 may be considered for study 3133K1-3002 participation if the abnormality is resolved and the subject met criteria to resume investigational product. Sponsor clinician physician approval to resume investigational product infusions is required prior to enrollment.
3. Brain MRI scan from Week 71 of study 3133K1-3000 is available for local radiology and central radiology evaluation and remains consistent with the diagnosis of AD.
4. MMSE score =10 at screening (Week 78 of 3133K1-3000).
5. Continues to live at home or is community dwelling with appropriate caregiver capable of accompanying the subject on all clinic visits and visiting with the subject at least 5 days per week, on average for the duration of the study.
6. In the opinion of the principal investigator, the subject and the caregiver will be compliant, and likely to participate in all scheduled evaluations.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 790

Exclusion Criteria

1. Any medical or psychiatric contraindication (e.g. suicidal ideation/behaviour) or clinically significant abnormality on physical, neurological, laboratory, vital signs or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that in the investigator's judgement will significantly increase the risk associated with the subject's participation in, and competion of the study, or could preclude the evaluation of the subject’s response.
2. Brain MRI scan from study 3133K1-3000 Week 71 visit indicative of any significant abnormality, including but not limited to more than 4 microhemorrhages (<10mm), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarct (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 (e.g., arachnoid cysts or brain tumors such as meningioma).
3. Use of any investigational drugs or devices, other than bapineuzumab, within the last 60 days prior to screening.
4. Current use of herbal preparations containing ginkgo biloba, or use of anticoagulants.
NOTE: Platelet anti-aggregants (e.g., aspirin 325 mg/day or less, clopidogrel bisulfate, dipyridamole for indications other than stroke) are allowed.

;
1. Any medical or psychiatric contraindication (e.g. suicidal ideation/behaviour) or clinically significant abnormality on physical, neurological, laboratory, vital signs or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that in the investigator's judgement will significantly increase the risk associated with the subject's participation in, and competion of the study, or could preclude the evaluation of the subject’s response.
2. Brain MRI scan from study 3133K1-3000 Week 71 visit indicative of any significant abnormality, including but not limited to more than 4 microhemorrhages (<10mm), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarct (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 (e.g., arachnoid cysts or brain tumors such as meningioma).
3. Use of any investigational drugs or devices, other than bapineuzumab, within the last 60 days prior to screening.
4. Current use of herbal preparations containing ginkgo biloba, or use of anticoagulants.
NOTE: Platelet anti-aggregants (e.g., aspirin 325 mg/day or less, clopidogrel bisulfate, dipyridamole for indications other than stroke) are allowed.

Study & Design

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