UCB Biopharma SRL
The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).
Alzheimer's Disease
Placebo
Bepranemab
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 421 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer's Disease (AD), Followed by an Open-Label Extension Period |
Actual Study Start Date : | June 9, 2021 |
Estimated Primary Completion Date : | May 20, 2024 |
Estimated Study Completion Date : | July 28, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Dose level 1 bepranemab Participants randomized to this arm will receive pre-specified doses (Dose level 1) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period. |
Biological: Bepranemab |
Experimental: Dose level 2 bepranemab Participants randomized to this arm will receive pre-specified doses (Dose level 2) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period. |
Biological: Bepranemab |
Placebo Comparator: Placebo Arm Participants randomized to this arm will receive Placebo to maintain the blinding during the Double-blind Treatment Period and will re-randomized during the Open-label Extension Period to receive pre-specified doses of bepranemab. |
Other: Placebo |
Ages Eligible for Study: | 50 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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Fresno, California, United States, 93710
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Fullerton, California, United States, 92835
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Irvine, California, United States, 92614
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Long Beach, California, United States, 90807
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Palo Alto, California, United States, 94303
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Pasadena, California, United States, 91105
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San Diego, California, United States, 92123
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Santa Ana, California, United States, 92705
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New Haven, Connecticut, United States, 06510
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New Haven, Connecticut, United States, 06510
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Stamford, Connecticut, United States, 06905
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Atlantis, Florida, United States, 33462
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Aventura, Florida, United States, 33180
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Boca Raton, Florida, United States, 33487
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Delray Beach, Florida, United States, 33445
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Fort Myers, Florida, United States, 33912
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Hialeah, Florida, United States, 33016
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Maitland, Florida, United States, 32751
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Miami, Florida, United States, 33125
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Naples, Florida, United States, 34105
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Ocoee, Florida, United States, 34761
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Pensacola, Florida, United States, 32502
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Pensacola, Florida, United States, 32503
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Port Orange, Florida, United States, 32127
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Tampa, Florida, United States, 33613
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West Palm Beach, Florida, United States, 33407
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West Palm Beach, Florida, United States, 33409
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Westchester, Florida, United States, 33155
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Decatur, Georgia, United States, 30033
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Braintree, Massachusetts, United States, 02184
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Newton, Massachusetts, United States, 02459
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Saint Paul, Minnesota, United States, 55130
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Neptune, New Jersey, United States, 07753
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Cincinnati, Ohio, United States, 45219
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East Providence, Rhode Island, United States, 02914
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Cordova, Tennessee, United States, 38018
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Houston, Texas, United States, 77054
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Fairfax, Virginia, United States, 22031
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Norfolk, Virginia, United States, 23507
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Bellevue, Washington, United States, 98007
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Brussels, Belgium,
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Brussels, Belgium,
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Kortrijk, Belgium,
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Leuven, Belgium,
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Kelowna, Canada,
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Ottawa, Canada,
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QC, Canada,
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Toronto, Canada,
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Toronto, Canada,
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Toronto, Canada,
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West Vancouver, Canada,
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Bordeaux, France,
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Bron Cedex, France,
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Marseille, France,
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Nantes, France,
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Paris, France,
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Rennes, France,
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Toulouse, France,
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Villeurbanne, France,
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Berlin, Germany,
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Munich, Germany,
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Monza, Italy,
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Parma, Italy,
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Pavia, Italy,
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Roma, Italy,
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Rome, Italy,
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Rome, Italy,
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Amsterdam, Netherlands,
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Den Bosch, Netherlands,
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Zwolle, Netherlands,
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Bialystok, Poland,
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Bydgoszcz, Poland,
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Katowice, Poland,
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Katowice, Poland,
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Scinawa, Poland,
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Szczecin, Poland,
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Warsaw, Poland,
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Warsaw, Poland,
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Warszawa, Poland,
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Wroclaw, Poland,
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Barcelona, Spain,
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Barcelona, Spain,
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Barcelona, Spain,
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Barcelona, Spain,
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Cordoba, Spain,
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Donostia, Spain,
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Madrid, Spain,
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Madrid, Spain,
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Pamplona, Spain,
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Sant Cugat Del Valles, Spain,
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Sevilla, Spain,
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Terrassa, Spain,
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Valencia, Spain,
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Valencia, Spain,
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Zaragoza, Spain,
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Birmingham, United Kingdom,
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Bristol, United Kingdom,
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Guildford, United Kingdom,
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London, United Kingdom,
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London, United Kingdom,
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Plymouth, United Kingdom,
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Winchester, United Kingdom,