Start: June 9, 2021
End: July 1, 2025
What Is This Study About?
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.
Do I Qualify To Participate in This Study?
- Diagnosis of mild cognitive impairment (MCI) or early-stage Alzheimer's disease with:
- Clinical Dementia Rating (CDR) score of 0.5 to 1
- CDR-Memory score > 0.5
- Mini-Mental State Examination score > 20
- Friend or family member who has frequent contact with the participant (at least five hours a week) and is available during the study to provide information on any changes in the participants emotions, memory, or daily functioning
- At least six years of education after the age of five or work experience to demonstrate normal cognitive abilities other than MCI or Alzheimer's
- Evidence of amyloid plaques in the brain, based on study screening test results
Must NOT have:
- Any condition that may affect cognition, other than mild cognitive impairment or Alzheimer's disease
- Any serious medical condition or abnormality that could interfere with study results or make the study unsafe, including:
- Any condition that could make having an MRI or PET brain scan unsafe (e.g., metal shrapnel, heart pacemaker, severe claustrophobia, epilepsy)
- Alcohol or drug abuse within two years prior to study screening
- Taking any medication that could interfere with the study, including:
- Experimental therapy within six months prior to study screening
- Any medication intended to treat a neurodegenerative disorder within one year prior to study screening; Alzheimer's disease medications are acceptable
- Long-term, daily treatment with certain antipsychotics, opioids, benzodiazepines, barbiturates, hypnotics, or any medication with strong anticholinergic or antihistamine effects
- Monoclonal antibody, cytokine, immunoglobulin, or other blood-derived therapies within three months of first dose of the study drug
If I Qualify, Who Do I Contact?
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.
Where Is This Study Located?
Lead: UCB Biopharma SRL
Source: ClinicalTrials.gov ID: NCT04867616