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
CELIA
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
2 other identifiers
interventional
416
17 countries
138
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
Longer than P75 for phase_2
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 8, 2029
May 18, 2025
May 1, 2025
3.7 years
May 27, 2022
May 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Dose response in Change From Baseline to Week 76 on the CDR-SB
The Clinical Dementia Rating (CDR) scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The CDR-SB is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
Baseline to Week 76
Secondary Outcomes (7)
Change From Baseline to Week 76 on the CDR-SB
Baseline to Week 76
Change From Baseline to Week 76 on the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI)
Baseline to Week 76
Change From Baseline to Week 76 on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 13)
Baseline to Week 76
Change From Baseline to Week 76 on the Mini Mental State Examination (MMSE)
Baseline to Week 76
Change From Baseline to Week 76 on the Modified Integrated Alzheimer's Disease Rating Scale (iADRS)
Baseline to Week 76
- +2 more secondary outcomes
Study Arms (4)
Placebo Q12W
PLACEBO COMPARATORParticipants will receive BIIB080-matching placebo, intrathecal (IT) injection, once on Day 1 and then once every 12 weeks (Q12W) for up to 72 weeks, during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will be randomized to receive BIIB080 high dose, IT injection, either Q12W or once every 24 weeks (Q24W) for an additional 96 weeks.
BIIB080 Low Dose Q24W
EXPERIMENTALParticipants will receive a low dose of BIIB080, IT injection, Q24W from Week 1 up to 72 weeks and BIIB080-matching placebo, IT injection, once at Weeks 12, 36, and 60 during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will continue to receive BIIB080 low dose, IT injection, Q24W for an additional 96 weeks.
BIIB080 High Dose Q24W
EXPERIMENTALParticipants will receive a high dose of BIIB080, IT injection, Q24W from Week 1 up to 72 weeks and BIIB080-matching placebo, IT injection, once at Weeks 12, 36, and 60 during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will continue to receive BIIB080 high dose, IT injection, Q24W for an additional 96 weeks.
BIIB080 High Dose Q12W
EXPERIMENTALParticipants will receive a high dose of BIIB080, IT injection, once on Day 1 and then Q12W for up to 72 weeks during the placebo-controlled period. Eligible participants will enter the LTE period, during which they will continue to receive BIIB080 high dose, IT injection, Q12W for an additional 96 weeks.
Interventions
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Eligibility Criteria
You may qualify if:
- 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:
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index score of ≤85, indicative of objective evidence of memory impairment.
- CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia
- MMSE score of 21 to 30 (inclusive).
- 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.
- 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.
You may not qualify if:
- 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 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (138)
Xenoscience Inc.
Phoenix, Arizona, 85004, United States
HonorHealth Neurology
Scottsdale, Arizona, 85251, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Mary S. Easton Center for Alzheimer's Disease Research, UCLA
Los Angeles, California, 90095, United States
PNS Clinical Research, LLC dba
Orange, California, 92868, United States
Stanford Hospital and Clinics
Palo Alto, California, 94304, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
University of California San Diego Medical Center
San Diego, California, 92103, United States
University of California San Francisco (PARENT)
San Francisco, California, 94143, United States
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, 80113, United States
Charter Research, LLC
Lady Lake, Florida, 32159, United States
K2 Medical Research, LLC
Orlando, Florida, 32751, United States
Advent Health
Orlando, Florida, 32804, United States
Conquest Research
Winter Park, Florida, 32789, United States
Charter Research, LLC
Winter Park, Florida, 32792, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Brigham and Women's Hospital Department of Neurology
Boston, Massachusetts, 02115-5804, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02216, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, 01805, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Neurological Associates of Albany, PC
Albany, New York, 12208, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
New York University Medical Center PRIME
New York, New York, 10016, United States
South Shore Neurologic Associates, P.C.
Patchogue, New York, 11772, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Duke University
Durham, North Carolina, 27710, United States
AMC Research, LLC
Matthews, North Carolina, 28105, United States
NeuroScience Research Center, LLC.
Canton, Ohio, 44718, United States
University of Cincinnati Physicians Group, LLC
Cincinnati, Ohio, 45206-0829, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Neurology Clinic, PC
Cordova, Tennessee, 38018, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
EvergreenHealth
Kirkland, Washington, 98034, United States
Kingfisher Cooperative, LLC
Spokane, Washington, 99202, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Southern Neurology
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
The Medical Arts Health Research Group
Kamloops, British Columbia, V2C 5T1, Canada
UBC Hospital
Vancouver, British Columbia, V6T 2B5, Canada
Medical Arts Health Research Group
West Vancouver, British Columbia, V7T 1C5, Canada
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, M3B 2S7, Canada
Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, J8T 8J1, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal, Quebec, H3A 2B4, Canada
Jewish General Hospital - NETWORK
Montreal, Quebec, H3T 1E2, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Fakultni nemocnice Ostrava
Ostrava, 70852, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
FORBELI s.r.o.
Prague, 16000, Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 516 01, Czechia
Ålborg Universitets Hospital
Aalborg, 9100, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Itä-Suomen yliopisto, Kuopion kampus
Kuopio, 70210, Finland
CRST, Clinical Research Services Turku
Turku, 20520, Finland
CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Bas Rhin, 67000, France
Hopital Purpan
Toulouse, Haute Garonne, 31059, France
Hôpital La Grave
Toulouse, Haute Garonne, 31059, France
Hopital Gui de Chauliac
Montpellier, Herault, 34295, France
CHU Nantes - Hopital Nord Laënnec
Saint-Herblain, Loire Atlantique, 44800, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, 59037, France
Hôpital Lariboisière
Paris, Paris, 75010, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, 76031, France
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013, France
Universitaetsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Klinikum Bayreuth GmbH- Hohe Warte
Bayreuth, Bavaria, 95445, Germany
Klinikum der Universität München
München, Bavaria, 81377, Germany
Neuro Centrum Science GmbH
Erbach im Odenwald, Hesse, 64711, Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, 37075, Germany
Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, 4600, Germany
Charité - Campus Charité Mitte
Berlin, 10117, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13125, Germany
Katholisches Klinikum Bochum gGmbH
Bochum, 44791, Germany
Azienda Ospedaliera Card. G. Panico
Tricase, Lecce, 73039, Italy
Fondazione Istituto G.Giglio di Cefalù
Cefalù, Palermo, 90015, Italy
Ospedale di Arzignano
Arzignano VI, Vicenza, 36071, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Azienda Ospedaliera e Universitaria di Perugia
Perugia, 06156, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 185, Italy
Ehime University Hospital
Toon-shi, Ehime, 791-0295, Japan
Himeji Central Hospital Clinic
Himeji-shi, Hyōgo, 672-8043, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Itabashi-ku, Tokyo-To, 173-0015, Japan
Brain Research Center Amsterdam
Amsterdam, Amsterdam, Netherlands
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756, Poland
PROMENTE Sp. z o.o.
Bydgoszcz, 85-133, Poland
Nzoz Novo-Med
Katowice, 40-650, Poland
Care Clinic Centrum Medyczne
Katowice, 40568, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 30-688, Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, 92-213, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Kliniczny Oddział Neurologii Oddział Udarowy
Lublin, 20-954, Poland
Centrum Medyczne Senior
Sopot, 81-855, Poland
NeuroProtect Sp. z o.o.
Warsaw, 01-684, Poland
Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
Warsaw, 03-242, Poland
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
CAE Oroitu
Getxo, Vizcaya, 48993, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025, Spain
Fundacio ACE
Barcelona, 8028, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitari de Santa Maria
Lleida, 25198, Spain
Hospital Victoria Eugenia
Seville, 41009, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Mölndal, 43180, Sweden
Karolinska universitetssjukhuset - Huddinge
Stockholm, 14186, Sweden
Ospedale Regionale di Lugano
Lugano, Canton Ticino, 6903, Switzerland
Spitalzentrum Biel
Biel/Bienne, 2501, Switzerland
Hôpitaux Universitaires de Genève - HUG- Centre de la mémoire, Bâtiment A1 - Morier
Geneva, 1205, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Institute of Psychiatry, Psychology and Neuroscience
London, Greater London, SE5 8AF, United Kingdom
Re:Cognition Health Ltd (London)
London, Greater London, W1G 9RU, United Kingdom
Charing Cross Hospital
London, Greater London, W6 8RF, United Kingdom
The National Hospital for Neurology and Neurosurgery Centre
London, Greater London, WC1N 3BG, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL, United Kingdom
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Warneford Hospital
Oxford, Oxfordshire, OX3 7JX, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
NeuroClin Limited
Motherwell, Strathclyde, ML1 4UF, United Kingdom
Re:Cognition Health - Birmingham
Birmingham, West Midlands, B16 8LT, United Kingdom
Re Cognition Health Bristol
Bristol, BS32 4SY, United Kingdom
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
August 24, 2022
Primary Completion (Estimated)
May 14, 2026
Study Completion (Estimated)
January 8, 2029
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/