Mild to Moderate Alzheimers Disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: AAB-001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bapineuzumab
Current Sponsor code: AAB-001
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
Elan Regulatory Holdings Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent obtained from the patient and the patient’s caregiver in accordance with the local regulations. 2. Patients must have completed Study 201 or Study 202 Visit 22 (Week 78), or Study 102 Visit 11 (Week 16). 3. Study 201 or Study 202 Visit 21 (Week 71), or Study 251 Screening Visit for patients from Study 102, MRI scan of sufficient quality for the Radiologist to evaluate patient safety. 4. Diagnosis of Probable Alzheimer’s disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria. 5. Lives at home with appropriate caregiver capable of accompanying the patient on all clinic visits, or community dwelling with caregiver capable of accompanying the patient on all clinic visits and visiting with the patient approximately 5 times per week for the duration of the study. 6. In the opinion of the investigator, the patient and the 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
Exclusion criteria
Exclusion criteria: 1. Significant neurological disease other than AD that may affect cognition. 2. Screening visit (i.e., Study 201 or Study 202 Visit 21:Week 71, or for Study 102, the Study 251 Screening Visit) brain MRI scan indicative of any other significant abnormality including but not limited to multiple microhemorrhages or 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, arachnoid cysts, or brain tumors (e.g., meningioma) unless approved by the medical monitor. 3. Current presence of a clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) or any clinically significant symptom that could affect the patient’s ability to complete the study. 4. Current clinically significant systemic illness that is likely to result in deterioration of the patient’s condition or affect the patient’s safety during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of long-term treatment of AAB 001 in patients with AD.;Secondary Objective: To evaluate the efficacy of long-term treatment of AAB-001 in patients with AD.;Primary end point(s): • The incidence and severity of treatment-emergent adverse events (TEAEs); • Clinically important changes in safety assessment results (including, as appropriate, vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], physical and neurological examinations, and infusion site assessments). | — |
Countries
Finland, United Kingdom
Outcome results
None listed