Bepranemab for Mild Cognitive Impairment or Early-Stage Alzheimer's Disease

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?

Must have:

• 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.

Where Is This Study Located?

Arizona
Ah0003 50305 Sun City, AZ 85351 Recruiting
California
Ah0003 50428 Fresno, CA 93710 Recruiting
Ah0003 50431 Fullerton, CA 92835 Recruiting
Ah0003 50442 Irvine, CA 92614 Recruiting
Ah0003 50458 Long Beach, CA 90807 Recruiting
Ah0003 50450 Palo Alto, CA 94303 Recruiting
Ah0003 50452 Pasadena, CA 91105 Recruiting
Ah0003 50447 San Diego, CA 92123 Recruiting
Ah0003 50434 Santa Ana, CA 92705 Recruiting
Connecticut
Ah0003 50422 New Haven, CT 06510 Recruiting
Ah0003 50467 New Haven, CT 06510 Recruiting
Ah0003 50421 Stamford, CT 06905 Recruiting
Florida
Ah0003 50465 Atlantis, FL 33462 Recruiting
Ah0003 50449 Aventura, FL 33180 Recruiting
Ah0003 50435 Boca Raton, FL 33487 Recruiting
Ah0003 50437 Boynton Beach, FL 33437 Recruiting
Ah0003 50430 Delray Beach, FL 33445 Recruiting
Ah0003 50429 Fort Myers, FL 33912 Recruiting
Ah0003 50436 Hialeah, FL 33016 Recruiting
Ah0003 50426 Maitland, FL 32751 Recruiting
Ah0003 50427 Miami, FL 33172 Recruiting
Ah0003 50478 Naples, FL 34105 Recruiting
Ah0003 50464 Ocoee, FL 34761 Recruiting
Ah0003 50438 Pensacola, FL 32502 Recruiting
Ah0003 50457 Port Orange, FL 32127 Recruiting
Ah0003 50454 Tampa, FL 33613 Recruiting
Ah0003 50444 West Palm Beach, FL 33407 Recruiting
Ah0003 50476 West Palm Beach, FL 33409 Recruiting
Ah0003 50446 Westchester, FL 33155 Recruiting
Georgia
Ah0003 50479 Decatur, GA 30033 Recruiting
Kentucky
Ah0003 50439 Lexington, KY 40504 Recruiting
Massachusetts
Ah0003 50445 Braintree, MA 02184 Recruiting
Ah0003 50453 Newton, MA 02459 Recruiting
Minnesota
Ah0003 50448 Saint Paul, MN 55130 Recruiting
New Jersey
Ah0003 50420 Neptune, NJ 07753 Recruiting
Ohio
Ah0003 50451 Cincinnati, OH 45219 Recruiting
Ah0003 50255 Columbus, OH 43210 Recruiting
Oregon
Ah0003 50443 Portland, OR 97210 Recruiting
Rhode Island
Ah0003 50423 East Providence, RI 02914 Recruiting
Tennessee
Ah0003 50455 Cordova, TN 38018 Recruiting
Texas
Ah0003 50380 Houston, TX 77478 Recruiting
Virginia
Ah0003 50424 Fairfax, VA 22031 Recruiting
Ah0003 50432 Norfolk, VA 23507 Recruiting
Washington
Ah0003 50440 Bellevue, WA 98007 Recruiting

Who Sponsors This Study?

Lead: UCB Biopharma SRL

Source: ClinicalTrials.gov ID: NCT04867616