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NCT04867616 | Active, not recruiting | Alzheimer's Disease


A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
Sponsor:

UCB Biopharma SRL

Brief Summary:

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).

Condition or disease

Alzheimer's Disease

Intervention/treatment

Placebo

Bepranemab

Phase

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
Criteria
Inclusion Criteria
  • 50 to 80 years of age
  • Diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
  • A global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDR-Memory Box (CDRMB) score ≥0.5 at Screening and Baseline
  • Score of ≤85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
  • Mini-Mental State Examination (MMSE) score ≥20 at Screening
  • Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
  • At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia
  • Evidence of cerebral Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment
Exclusion Criteria
  • Any evidence of a condition that may affect cognition other than AD
  • Contraindications to PET imaging
  • Inability to tolerate or contraindication to magnetic resonance imaging
  • Any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
  • Alcohol or drug abuse within 2 years of screening
  • Use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening
  • Previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening
  • Chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy
  • Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing

A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)

Location Details


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A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, California

Ah0003 50428

Fresno, California, United States, 93710

Not yet recruiting

United States, California

Ah0003 50431

Fullerton, California, United States, 92835

Not yet recruiting

United States, California

Ah0003 50442

Irvine, California, United States, 92614

Not yet recruiting

United States, California

Ah0003 50458

Long Beach, California, United States, 90807

Not yet recruiting

United States, California

Ah0003 50450

Palo Alto, California, United States, 94303

Not yet recruiting

United States, California

Ah0003 50452

Pasadena, California, United States, 91105

Not yet recruiting

United States, California

Ah0003 50447

San Diego, California, United States, 92123

Not yet recruiting

United States, California

Ah0003 50434

Santa Ana, California, United States, 92705

Not yet recruiting

United States, Connecticut

Ah0003 50422

New Haven, Connecticut, United States, 06510

Not yet recruiting

United States, Connecticut

Ah0003 50467

New Haven, Connecticut, United States, 06510

Not yet recruiting

United States, Connecticut

Ah0003 50421

Stamford, Connecticut, United States, 06905

Not yet recruiting

United States, Florida

Ah0003 50465

Atlantis, Florida, United States, 33462

Not yet recruiting

United States, Florida

Ah0003 50449

Aventura, Florida, United States, 33180

Not yet recruiting

United States, Florida

Ah0003 50435

Boca Raton, Florida, United States, 33487

Not yet recruiting

United States, Florida

Ah0003 50430

Delray Beach, Florida, United States, 33445

Not yet recruiting

United States, Florida

Ah0003 50429

Fort Myers, Florida, United States, 33912

Not yet recruiting

United States, Florida

Ah0003 50436

Hialeah, Florida, United States, 33016

Not yet recruiting

United States, Florida

Ah0003 50426

Maitland, Florida, United States, 32751

Not yet recruiting

United States, Florida

Ah0003 50427

Miami, Florida, United States, 33125

Not yet recruiting

United States, Florida

Ah0003 50478

Naples, Florida, United States, 34105

Not yet recruiting

United States, Florida

Ah0003 50464

Ocoee, Florida, United States, 34761

Not yet recruiting

United States, Florida

Ah0003 50438

Pensacola, Florida, United States, 32502

Not yet recruiting

United States, Florida

Ah0003 50623

Pensacola, Florida, United States, 32503

Not yet recruiting

United States, Florida

Ah0003 50457

Port Orange, Florida, United States, 32127

Not yet recruiting

United States, Florida

Ah0003 50454

Tampa, Florida, United States, 33613

Not yet recruiting

United States, Florida

Ah0003 50444

West Palm Beach, Florida, United States, 33407

Not yet recruiting

United States, Florida

Ah0003 50476

West Palm Beach, Florida, United States, 33409

Not yet recruiting

United States, Florida

Ah0003 50446

Westchester, Florida, United States, 33155

Not yet recruiting

United States, Georgia

Ah0003 50479

Decatur, Georgia, United States, 30033

Not yet recruiting

United States, Massachusetts

Ah0003 50445

Braintree, Massachusetts, United States, 02184

Not yet recruiting

United States, Massachusetts

Ah0003 50453

Newton, Massachusetts, United States, 02459

Not yet recruiting

United States, Minnesota

Ah0003 50448

Saint Paul, Minnesota, United States, 55130

Not yet recruiting

United States, New Jersey

Ah0003 50420

Neptune, New Jersey, United States, 07753

Not yet recruiting

United States, Ohio

Ah0003 50451

Cincinnati, Ohio, United States, 45219

Not yet recruiting

United States, Rhode Island

Ah0003 50423

East Providence, Rhode Island, United States, 02914

Not yet recruiting

United States, Tennessee

Ah0003 50455

Cordova, Tennessee, United States, 38018

Not yet recruiting

United States, Texas

Ah0003 50380

Houston, Texas, United States, 77054

Not yet recruiting

United States, Virginia

Ah0003 50424

Fairfax, Virginia, United States, 22031

Not yet recruiting

United States, Virginia

Ah0003 50432

Norfolk, Virginia, United States, 23507

Not yet recruiting

United States, Washington

Ah0003 50440

Bellevue, Washington, United States, 98007

Not yet recruiting

Belgium,

Ah0003 40123

Brussels, Belgium,

Not yet recruiting

Belgium,

Ah0003 40575

Brussels, Belgium,

Not yet recruiting

Belgium,

Ah0003 40576

Kortrijk, Belgium,

Not yet recruiting

Belgium,

Ah0003 40002

Leuven, Belgium,

Not yet recruiting

Canada,

Ah0003 50463

Kelowna, Canada,

Not yet recruiting

Canada,

Ah0003 50461

Ottawa, Canada,

Not yet recruiting

Canada,

Ah0003 50520

QC, Canada,

Not yet recruiting

Canada,

Ah0003 50045

Toronto, Canada,

Not yet recruiting

Canada,

Ah0003 50291

Toronto, Canada,

Not yet recruiting

Canada,

Ah0003 50462

Toronto, Canada,

Not yet recruiting

Canada,

Ah0003 50522

West Vancouver, Canada,

Not yet recruiting

France,

Ah0003 40129

Bordeaux, France,

Not yet recruiting

France,

Ah0003 40580

Bron Cedex, France,

Not yet recruiting

France,

Ah0003 40493

Marseille, France,

Not yet recruiting

France,

Ah0003 40635

Nantes, France,

Not yet recruiting

France,

Ah0003 40578

Paris, France,

Not yet recruiting

France,

Ah0003 40201

Rennes, France,

Not yet recruiting

France,

Ah0003 40581

Toulouse, France,

Not yet recruiting

France,

Ah0003 40579

Villeurbanne, France,

Not yet recruiting

Germany,

Ah0003 40028

Berlin, Germany,

Not yet recruiting

Germany,

Ah0003 40430

Munich, Germany,

Not yet recruiting

Italy,

Ah0003 40371

Monza, Italy,

Not yet recruiting

Italy,

Ah0003 40600

Parma, Italy,

Not yet recruiting

Italy,

Ah0003 40597

Pavia, Italy,

Not yet recruiting

Italy,

Ah0003 40438

Roma, Italy,

Not yet recruiting

Italy,

Ah0003 40596

Rome, Italy,

Not yet recruiting

Italy,

Ah0003 40598

Rome, Italy,

Not yet recruiting

Netherlands,

Ah0003 40450

Amsterdam, Netherlands,

Not yet recruiting

Netherlands,

Ah0003 40449

Den Bosch, Netherlands,

Not yet recruiting

Netherlands,

Ah0003 40601

Zwolle, Netherlands,

Not yet recruiting

Poland,

Ah0003 40603

Bialystok, Poland,

Not yet recruiting

Poland,

Ah0003 40606

Bydgoszcz, Poland,

Not yet recruiting

Poland,

Ah0003 40605

Katowice, Poland,

Not yet recruiting

Poland,

Ah0003 40609

Katowice, Poland,

Not yet recruiting

Poland,

Ah0003 40638

Scinawa, Poland,

Not yet recruiting

Poland,

Ah0003 40608

Szczecin, Poland,

Not yet recruiting

Poland,

Ah0003 40604

Warsaw, Poland,

Not yet recruiting

Poland,

Ah0003 40607

Warsaw, Poland,

Not yet recruiting

Poland,

Ah0003 40602

Warszawa, Poland,

Not yet recruiting

Poland,

Ah0003 40611

Wroclaw, Poland,

Not yet recruiting

Spain,

Ah0003 40159

Barcelona, Spain,

Not yet recruiting

Spain,

Ah0003 40160

Barcelona, Spain,

Not yet recruiting

Spain,

Ah0003 40267

Barcelona, Spain,

Not yet recruiting

Spain,

Ah0003 40612

Barcelona, Spain,

Not yet recruiting

Spain,

Ah0003 40105

Cordoba, Spain,

Not yet recruiting

Spain,

Ah0003 40614

Donostia, Spain,

Not yet recruiting

Spain,

Ah0003 40540

Madrid, Spain,

Not yet recruiting

Spain,

Ah0003 40615

Madrid, Spain,

Not yet recruiting

Spain,

Ah0003 40352

Pamplona, Spain,

Not yet recruiting

Spain,

Ah0003 40280

Sant Cugat Del Valles, Spain,

Not yet recruiting

Spain,

Ah0003 40049

Sevilla, Spain,

Not yet recruiting

Spain,

Ah0003 40453

Terrassa, Spain,

Not yet recruiting

Spain,

Ah0003 40230

Valencia, Spain,

Not yet recruiting

Spain,

Ah0003 40613

Valencia, Spain,

Not yet recruiting

Spain,

Ah0003 40616

Zaragoza, Spain,

Not yet recruiting

United Kingdom,

Ah0003 40662

Birmingham, United Kingdom,

Not yet recruiting

United Kingdom,

Ah0003 40619

Bristol, United Kingdom,

Not yet recruiting

United Kingdom,

Ah0003 40622

Guildford, United Kingdom,

Not yet recruiting

United Kingdom,

Ah0003 40618

London, United Kingdom,

Not yet recruiting

United Kingdom,

Ah0003 40621

London, United Kingdom,

Not yet recruiting

United Kingdom,

Ah0003 40623

Plymouth, United Kingdom,

Not yet recruiting

United Kingdom,

Ah0003 40691

Winchester, United Kingdom,

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