Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05399888

PHASE2

A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

Sponsor: Biogen

View on ClinicalTrials.gov

Summary

In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD. The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most. To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB. * Clinicians use the CDR-SB to measure several categories of dementia symptoms. * The results for each category are added together for a total score. Lower scores are better. Researchers will also learn more about the safety of BIIB080. The study will be split into 2 parts. The 1st part is the Placebo-Controlled Period. The 2nd part is the Long-Term Extension (LTE) Period. The 2nd part of the study will help researchers learn about the long-term safety of BIIB080, and how it affects the participant's daily life, thinking, and memory abilities in the longer term. A description of how the study will be done is given below. * After screening, participants will first receive either a low dose or high dose of BIIB080, or a placebo, as an injection into the fluid around the spinal cord (cerebrospinal fluid). A placebo looks like the study drug but contains no real medicine. * Participants will receive BIIB080 or placebo once every 12 weeks or 24 weeks. * After 76 weeks of treatment in the Placebo-Controlled Period, eligible participants will move onto the Extension Treatment period, which will last 96 weeks. * In the extension period, participants who received placebo will be switched to high dose BIIB080 every 12 or 24 weeks. * Participants may be in the study for up to 201 weeks, or about 4 years. This includes the screening and follow-up periods. * Participants can continue to take certain medications for AD. Participants must be on the same dose of medication for at least 8 weeks before the screening period. * After the screening period, most participants will visit the clinic every 6 weeks.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease Dementia

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2022-08-24

Completion Date

2029-01-08

Last Updated

2025-05-18

Healthy Volunteers

Conditions

Mild Cognitive Impairment Due to Alzheimer's Disease Alzheimer's Disease Dementia

Interventions

DRUG

BIIB080

Administered as specified in the treatment arm.

DRUG

BIIB080-matching placebo

Administered as specified in the treatment arm.

Key Inclusion Criteria for Placebo-controlled Period: * Must meet all the clinical staging criteria for MCI due to AD (Stage 3) or mild AD dementia (Stage 4) according to the National Institute on Aging at National Institutes of Health and the Alzheimer's Association (NIA-AA) and must have the following at Screening Visit 1: 1. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index score of ≤85, indicative of objective evidence of memory impairment. 2. CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia 3. MMSE score of 21 to 30 (inclusive). 4. CDR Memory Box score of ≥0.5. * Evidence of amyloid pathology as measured by positive emission tomography (PET) or cerebrospinal fluid (CSF) sampling. * Must have 1 care partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant (at least 10 hours/week) to be able to provide accurate information about the participant's cognitive and functional abilities. Key Inclusion Criteria for LTE Period * Ability of the participant and/or his/her legally authorized representative (e.g., parent, spouse, or legal guardian), where local regulations and institutional practices permit, as appropriate and applicable, to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. Incapacitated individuals will not be enrolled in the EU (European Union) and other countries where local laws, regulations, and practices do not permit their inclusion. * Participants must have completed the placebo-controlled period of the study, including the Week 76 visit. * Participants must have taken at least 5 doses of BIIB080 or placebo during the placebo-controlled period. * Medically able to undergo the study procedures (including LP \[lumbar puncture\]) and to adhere to the visit schedule at the time of study entry into the LTE period, as determined by the Investigator. * Apart from a clinical diagnosis of AD, the participant must be in good health as determined by the Investigator, based on medical history. * Must have 1 care partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant (at least 10 hours/week) to be able to provide accurate information about the participant's cognitive and functional abilities. Key Exclusion Criteria for Placebo-controlled Period: * Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product. * Previous participation in this study or previous studies with BIIB080. * Use of non-disease-modifying AD medications (including but not limited to donepezil, rivastigmine, galantamine, tacrine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Day 1. * Use of any commercially available disease-modifying AD medications such as anti-amyloid monoclonal antibodies. * Prior participation in any active or passive immunotherapy study targeting Aβ, unless documentation of receipt of placebo is available. * Prior participation in any passive immunotherapy study targeting tau, unless the last administration occurred 6 months or 5 half-lives, whichever is sooner, prior to Screening or documentation of receipt of placebo is available. * Prior participation in any study involving an investigational treatment targeting tau that is not a passive immunotherapy, unless documentation of receipt of placebo is available. * Prior participation in a study of any other agent(s) not included in exclusion criteria 5, 6, and 7 with a purported disease-modifying effect in AD within 12 months, unless documentation of receipt of placebo is available. * Prior participation in a study of any gene therapy with a purported disease-modifying effect in AD, unless documentation of receipt of placebo is available. * Current use or previous use of medications with a purported disease-modifying effect in AD, outside of investigational studies. * Any vaccination given within 10 days prior to Day -1. Coronavirus disease 2019 (COVID-19) vaccinations using RNA or deoxyribonucleic acid (DNA) technology are allowed during the study, as well as other types of immunization/vaccination/booster, except during the 10 days before and after clinic visits. * Contraindications to having a brain magnetic resonance imaging (MRI) \[e.g., MRI-incompatible pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed\]. If the MRI compatibility of implanted devices is unknown, the participant must be excluded from the study. * Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 52 weeks prior to the Baseline Visit. Key Exclusion Criteria for LTE Period * Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (138)

Xenoscience Inc.

Phoenix, Arizona, United States

HonorHealth Neurology

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Mary S. Easton Center for Alzheimer's Disease Research, UCLA

Los Angeles, California, United States

PNS Clinical Research, LLC dba

Orange, California, United States

Stanford Hospital and Clinics

Palo Alto, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

University of California San Diego Medical Center

San Diego, California, United States

University of California San Francisco (PARENT)

San Francisco, California, United States

Rocky Mountain Movement Disorders Center, PC

Englewood, Colorado, United States

Charter Research, LLC

Lady Lake, Florida, United States

K2 Medical Research, LLC

Orlando, Florida, United States

Advent Health

Orlando, Florida, United States

Conquest Research

Winter Park, Florida, United States

Charter Research, LLC

Winter Park, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Brigham and Women's Hospital Department of Neurology

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Neurological Associates of Albany, PC

Albany, New York, United States

Dent Neurologic Institute

Amherst, New York, United States

New York University Medical Center PRIME

New York, New York, United States

South Shore Neurologic Associates, P.C.

Patchogue, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Duke University

Durham, North Carolina, United States

AMC Research, LLC

Matthews, North Carolina, United States

NeuroScience Research Center, LLC.

Canton, Ohio, United States

University of Cincinnati Physicians Group, LLC

Cincinnati, Ohio, United States

Butler Hospital

Providence, Rhode Island, United States

Neurology Clinic, PC

Cordova, Tennessee, United States

Neurology Consultants of Dallas, PA

Dallas, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

EvergreenHealth

Kirkland, Washington, United States

Kingfisher Cooperative, LLC

Spokane, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Southern Neurology

Kogarah, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

UZ Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

The Medical Arts Health Research Group

Kamloops, British Columbia, Canada

UBC Hospital

Vancouver, British Columbia, Canada

Medical Arts Health Research Group

West Vancouver, British Columbia, Canada

Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

Ottawa, Ontario, Canada

Toronto Memory Program (Neurology Research Inc.)

Toronto, Ontario, Canada

Clinique de la Memoire de l'Outaouais

Gatineau, Quebec, Canada

Montreal Neurological Institute Clinical Research Unit

Montreal, Quebec, Canada

Jewish General Hospital - NETWORK

Montreal, Quebec, Canada

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

FORBELI s.r.o.

Prague, Czechia

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, Czechia

Ålborg Universitets Hospital

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

Itä-Suomen yliopisto, Kuopion kampus

Kuopio, Finland

CRST, Clinical Research Services Turku

Turku, Finland

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, Bas Rhin, France

Hopital Purpan

Toulouse, Haute Garonne, France

Hôpital La Grave

Toulouse, Haute Garonne, France

Hopital Gui de Chauliac

Montpellier, Herault, France

CHU Nantes - Hopital Nord Laënnec

Saint-Herblain, Loire Atlantique, France

Hopital Roger Salengro - CHU Lille

Lille, Nord, France

Hôpital Lariboisière

Paris, Paris, France

CHU de Rouen - Hôpital Charles Nicolle

Rouen, Seine Maritime, France

Groupe Hospitalier Pitie-Salpetriere

Paris, France

Universitaetsmedizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Klinikum Bayreuth GmbH- Hohe Warte

Bayreuth, Bavaria, Germany

Klinikum der Universität München

München, Bavaria, Germany

Neuro Centrum Science GmbH

Erbach im Odenwald, Hesse, Germany

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, Germany

Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)

Bonn, North Rhine-Westphalia, Germany

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, Germany

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, Germany

Charité - Campus Charité Mitte

Berlin, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Katholisches Klinikum Bochum gGmbH

Bochum, Germany

Azienda Ospedaliera Card. G. Panico

Tricase, Lecce, Italy

Fondazione Istituto G.Giglio di Cefalù

Cefalù, Palermo, Italy

Ospedale di Arzignano

Arzignano VI, Vicenza, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Brescia, Italy

Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Azienda Ospedaliera e Universitaria di Perugia

Perugia, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

Roma, Italy

Ehime University Hospital

Toon-shi, Ehime, Japan

Himeji Central Hospital Clinic

Himeji-shi, Hyōgo, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki-shi, Kanagawa, Japan

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Itabashi-ku, Tokyo-To, Japan

Brain Research Center Amsterdam

Amsterdam, Netherlands

Podlaskie Centrum Psychogeriatrii

Bialystok, Poland

PROMENTE Sp. z o.o.

Bydgoszcz, Poland

Nzoz Novo-Med

Katowice, Poland

Care Clinic Centrum Medyczne

Katowice, Poland

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Kliniczny Oddział Neurologii Oddział Udarowy

Lublin, Poland

Centrum Medyczne Senior

Sopot, Poland

NeuroProtect Sp. z o.o.

Warsaw, Poland

Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

Warsaw, Poland

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

CAE Oroitu

Getxo, Vizcaya, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Fundacio ACE

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitari de Santa Maria

Lleida, Spain

Hospital Victoria Eugenia

Seville, Spain

Hospital Universitario Dr. Peset

Valencia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

Mölndal, Sweden

Karolinska universitetssjukhuset - Huddinge

Stockholm, Sweden

Ospedale Regionale di Lugano

Lugano, Canton Ticino, Switzerland

Spitalzentrum Biel

Biel/Bienne, Switzerland

Hôpitaux Universitaires de Genève - HUG- Centre de la mémoire, Bâtiment A1 - Morier

Geneva, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Institute of Psychiatry, Psychology and Neuroscience

London, Greater London, United Kingdom

Re:Cognition Health Ltd (London)

London, Greater London, United Kingdom

Charing Cross Hospital

London, Greater London, United Kingdom

The National Hospital for Neurology and Neurosurgery Centre

London, Greater London, United Kingdom

Greater Manchester Mental Health NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Warneford Hospital

Oxford, Oxfordshire, United Kingdom

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

NeuroClin Limited

Motherwell, Strathclyde, United Kingdom

Re:Cognition Health - Birmingham

Birmingham, West Midlands, United Kingdom

Re Cognition Health Bristol

Bristol, United Kingdom

Clinical Research Directory

A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (138)