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Baylor College of Medicine

CLARITY AD Study (H-45723)

Description

Content

The purpose of this study is to test whether an investigational drug called BAN2401 is better than placebo in slowing the rate of decline on several measures of memory and thinking abilities.  The drug will be tested by assigning half of the participants to receive an infusion of the study drug every two weeks for 18 weeks, and half of the participants to receive a placebo infusion.  The placebo is an inactive, harmless substance, like a sugar pill.  After 18 months, there is a possibility that all subjects who consent will receive the active drug for up to two years.  

To be eligible, participants must be diagnosed with MCI due to AD or early AD, be between 50 and 90 years old, and have evidence of amyloid accumulation in the brain by either a test of spinal fluid or an amyloid PET scan.  The screening process involves cognitive testing to make sure you meet criteria for MCI or early AD, labs, an ECG and MRI to rule serious health problems, and a PET scan to check for presence of amyloid. After randomization, you will return every two weeks for the study infusion. Study visits that include cognitive tests, other questionnaires, labs, and ECG to check for serious health problems will occur at 6, 12, and 18 months after randomization.  You will also have MRI’s done at 9 weeks, 13 weeks, 3 months, and 6 months after randomization to check for brain changes resulting from study medication.  

For more information contact Bobby Marker at (713) 798-2230 or Robert.Marker@bcm.edu.

Contact

Bobby Marker

Phone 1: 713–798–2230

IRB: H-45723

Status:

Active

Created:

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