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.

A study flyer with more details is attached.