Alzheimer’s Disease MedDRA version: 5.1 Level: HLT Classification code 10001897
Conditions
Interventions
Product Name: AAB-001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
Current Sponsor code: AAB-001
Other
Sponsors
Elan Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent obtained from the patient and/or the patient’s legally acceptable representative, if applicable, in accordance with the local regulations. 2. 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. 3. Age from 50 to 80 years, inclusive. 4. Mini-Mental State Examination (MMSE) score of 18-26. 5. Rosen Modified Hachinski Ischemic score =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. Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), or symptom (e.g., hallucinations), that could affect the patient’s ability to complete the study. 3. 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. 4. History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque. 5. History of seizures, excluding febrile seizures in childhood. 6. Weight greater than 120 kg (264 lbs). 7. History or evidence of any significant autoimmune disease or disorder of the immune system. 8. Clinically significant infection within the last 30 days (e.g., chronic persistent or acute infection). 9. Treatment with immunosuppressive medications (e.g., 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. 10. Myocardial infarction within the last 2 years. 11. History of cancer within the last 5 years, with the exception of basal cell carcinoma, and nonmetastatic squamous cell carcinoma of the skin. 12. Other clinically significant abnormality on physical, neurological, laboratory, or ECG examination (e.g., atrial fibrillation) that could compromise the study or be detrimental to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of multiple doses of AAB-001 in patients with mild to moderate Alzheimer’s disease (AD). To evaluate the effect of AAB-001 on brain amyloid burden in patients with mild to moderate AD. ;Secondary Objective: To evaluate the efficacy of AAB-001 in patients with mild to moderate 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], MRIs, and physical and neurological exams); Change from screening brain amyloid burden at Weeks 24, 50, and 78 on PET using the amyloid binding agent, Pittsburgh Compound B (PIB). Change from screening in regional cerebral metabolic rates for glucose at Week 78 on PET using fluoro-deoxyglucose (FDG). | — |
Countries
Finland, United Kingdom
Outcome results
None listed