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A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects with Early Alzheimer's Disease (BAN2401-G000-201)
What is the purpose of this research study?
The purpose of this clinical trial is to evaluate the efficacy, safety and tolerability of BAN2401, a drug that may have the potential to treat Alzheimer's disease (AD). In AD, there are abnormally-high levels of a protein, called amyloid beta, in the brain. We hope that BAN2401 can reduce the amount of amyloid.
Who is eligible?
We are looking for participants who:
-- have been diagnosed with Mild Cognitive Impairment (MCI) or mild Alzheimer's disease dementia
-- are between the age of 50 and 90
-- have a reliable caregiver or family member who knows them well and is able to accompany them to study visits
-- are in stable medical condition
-- are willing to undergo MRI and PET scans and optional lumbar punctures
People taking approved Alzheimer's medications (donepezil/Aricept, galantamine/Razadyne, rivastigmine/Exelon, memantine/Namenda) are eligible to take part in this study and can continue taking these medications during the study.
Please see the attached study description for more information.
|Eisai Web blurb.pdf||78.75 KB|