Start: June 9, 2021
End: July 1, 2025
Enrollment: 450
This Phase 2 study, called Together, will test the safety and effectiveness of the experimental drug bepranemab to improve memory and other cognitive functions in older adults with mild cognitive impairment or early-stage Alzheimer's disease. In the first phase of the study, participants will be randomly assigned to one of three groups; to receive an IV infusion of a placebo or one of two doses of the study drug for 20 months. In the next phase, those participants already receiving the study drug will continue to receive the same drug dosage. The participants receiving the placebo will be randomly assigned to one of two doses of the study drug for six months. All participants will undergo PET and MRI brain imaging at the start of the study and after 14 and 20 months. They will also complete a variety of cognitive tests and provide blood and cerebrospinal fluid (optional) samples. Researchers will also measure changes in cognitive and daily functioning, changes in the levels of proteins associated with Alzheimer's, and track the concentration of the study drug in the blood. In addition, the researchers will evaluate the safety of the drug during treatment and for one year after the last dose.
Minimum Age: 50 Years
Maximum Age: 80 Years
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information and to enroll, visit the Together study website.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Lead: UCB Biopharma SRL
Source: ClinicalTrials.gov ID: NCT04867616