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

Start: June 9, 2021
End: November 2025
Enrollment: 450

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?

Minimum Age: 50 Years

Maximum Age: 80 Years

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.

Study Contact
UCB Cares

Need Help?

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?

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