Alzheimer's Disease
Conditions
Keywords
Alzheimer's Caregivers, Alzheimer disease
Brief summary
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
Interventions
DRUGAAB-001
Sponsors
Pharmacology Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Inclusion criteria
* Diagnosis of probable AD * Age from 50 to 85 years, inclusive * Rosen Modified Hachinski ischemic score less than or equal to 4 * Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD * Fluency in English * Stable doses of medications
Exclusion criteria
* Significant neurological disease other than AD * Major psychiatric disorder * Significant systemic illness * History of stroke or seizure * Weight greater than 120kg (264 lbs.) * History of autoimmune disease * Smoking more than 20 cigarettes per day * Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications * Prior treatment with experimental immunotherapeutics or vaccines for AD * Presence of pacemakers or foreign metal objects in the eyes, skin, or body
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of administered study drug | — |
| Cognitive and functional assessments | — |
Countries
United States
Outcome results
None listed