A Study to Learn About the Safety of BIIB080 and Whether it 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)

April 15, 2024 updated by: Biogen

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

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BIIB080 is an investigational antisense therapy designed to target microtubule-associated protein tau (MAPT) mRNA and prevent production of tau protein.

Study Type

Interventional

Enrollment (Estimated)

735

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent'S Hospital Sydney
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • Southern Neurology
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Hospital Brisbane
  • Belgium
      • Brussel, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Principal Investigator:
          • Sebastiaan Engelborghs
        • Contact:
          • Phone Number: 3232803003
      • Bruxelles, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Phone Number: 3227645467
        • Principal Investigator:
          • Bernard Hanseeuw
      • Kortrijk, Belgium, 8500
        • Recruiting
        • AZ Groeninge
        • Principal Investigator:
          • Frederik Vanhee
        • Contact:
          • Phone Number: 3256633420
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Rik Vandenberghe
        • Contact:
          • Phone Number: 3216344280
  • Canada
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C 5T1
        • Completed
        • The Medical Arts Health Research Group
      • West Vancouver, British Columbia, Canada, V7T 1C5
        • Recruiting
        • Medical Arts Health Research Group
        • Principal Investigator:
          • Kevin Kjernisted
        • Contact:
          • Phone Number: 888-736-0667
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recruiting
        • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
        • Principal Investigator:
          • Robert Bisson
        • Contact:
          • Phone Number: 819-777-7668
      • Toronto, Ontario, Canada, M3B 2S7
        • Recruiting
        • Toronto Memory Program (Neurology Research Inc.)
        • Principal Investigator:
          • Sharon Cohen
        • Contact:
          • Phone Number: 416-386-9761
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Recruiting
        • Clinique de la Mémoire de l'Outaouais
        • Principal Investigator:
          • Richard Bergeron
        • Contact:
          • Phone Number: 819-510-1000
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital - NETWORK
        • Contact:
          • Phone Number: 41678525003956
        • Principal Investigator:
          • Howard Chertkow
      • Montréal, Quebec, Canada, H3A 2B4
        • Recruiting
        • Montreal Neurological Institute Clinical Research Unit
        • Principal Investigator:
          • Simon Ducharme
        • Contact:
          • Phone Number: 51439819111
  • Czechia
      • Brno, Czechia, 65691
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
        • Contact:
          • Phone Number: 420543182662
        • Principal Investigator:
          • Lenka Krajcovicova
      • Hradec Kralove, Czechia, 50005
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Contact:
          • Phone Number: 420495835250
        • Principal Investigator:
          • Filip Caisberger
      • Ostrava, Czechia, 70852
        • Recruiting
        • Fakultni nemocnice Ostrava
        • Contact:
          • Phone Number: 420553620921
        • Principal Investigator:
          • Michal Bar
      • Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole
        • Contact:
          • Phone Number: 420224434700
        • Principal Investigator:
          • Jakub Hort
      • Praha 6, Czechia, 16000
        • Recruiting
        • Forbeli s.r.o.
        • Principal Investigator:
          • Michal Bajacek
        • Contact:
          • Phone Number: 420233336271
      • Rychnov nad Kneznou, Czechia, 516 01
        • Recruiting
        • Vestra Clinics s.r.o.
        • Principal Investigator:
          • Ladislav Pazdera
        • Contact:
          • Phone Number: 420604236033
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Phone Number: 4535456911
        • Principal Investigator:
          • Kristian Steen Frederiksen
      • Ålborg, Denmark, 9100
        • Recruiting
        • Ålborg Universitets Hospital
        • Contact:
          • Phone Number: 4599321940
        • Principal Investigator:
          • Karsten Vestergaard
  • Finland
      • Kuopio, Finland, 70210
        • Recruiting
        • Itä-Suomen yliopisto, Kuopion kampus
        • Principal Investigator:
          • Sudhir Kurl
        • Contact:
          • Phone Number: 358403552966
      • Turku, Finland, 20520
        • Recruiting
        • CRST, Clinical Research Services Turku
        • Principal Investigator:
          • Juha Rinne
        • Contact:
          • Phone Number: 358504412400
  • France
      • Paris, France, 75013
        • Recruiting
        • Groupe Hospitalier Pitie-Salpetriere
        • Contact:
          • Phone Number: 33142161837
        • Principal Investigator:
          • Nicolas Villain
    • Bas Rhin
      • Strasbourg Cedex, Bas Rhin, France, 67000
        • Recruiting
        • CHU Strasbourg - Hôpital Hautepierre
        • Contact:
          • Phone Number: 33388128631
        • Principal Investigator:
          • Frederic Blanc
    • Haute Garonne
      • Toulouse Cedex 9, Haute Garonne, France, 31059
        • Recruiting
        • Hôpital La Grave
        • Contact:
          • Phone Number: 33561497649
        • Principal Investigator:
          • Pierre-Jean Ousset
      • Toulouse Cedex 9, Haute Garonne, France, 31059
        • Recruiting
        • Hôpital Purpan
        • Principal Investigator:
          • Jeremie Pariente
        • Contact:
          • Phone Number: 33561777686
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Hopital Gui de Chauliac
        • Contact:
          • Phone Number: 33467336733
        • Principal Investigator:
          • Karim Bennys
    • Loire Atlantique
      • Saint-Herblain, Loire Atlantique, France, 44800
        • Recruiting
        • CHU Nantes - Hopital Nord Laënnec
        • Contact:
          • Phone Number: 33240165422
        • Principal Investigator:
          • Claire Boutoleau Bretonniere
    • Nord
      • Lille Cedex, Nord, France, 59037
        • Recruiting
        • Hopital Roger Salengro - CHU Lille
        • Contact:
          • Phone Number: 33320446021
        • Principal Investigator:
          • Thibaud Lebouvier
    • Paris
      • Paris cedex 10, Paris, France, 75010
        • Recruiting
        • Hôpital Lariboisière
        • Contact:
          • Phone Number: 33140054313
        • Principal Investigator:
          • Claire Paquet
    • Seine Maritime
      • Rouen Cedex, Seine Maritime, France, 76031
        • Recruiting
        • CHU de Rouen - Hôpital Charles Nicolle
        • Principal Investigator:
          • Aline Zarea
        • Contact:
          • Phone Number: 33232888740
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Principal Investigator:
          • Oliver Peters
        • Contact:
          • Phone Number: 4930450517688
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Campus Charité Mitte
        • Contact:
          • Phone Number: 4930450560560
        • Principal Investigator:
          • Peter Koertvelyessy
      • Bochum, Germany, 44791
        • Recruiting
        • Katholisches Klinikum Bochum gGmbH
        • Contact:
          • Phone Number: 492345092411
        • Principal Investigator:
          • Siegfried Martin Muhlack
    • Baden Wuerttemberg
      • Tuebingen, Baden Wuerttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Principal Investigator:
          • Matthis Synofzik
        • Contact:
          • Phone Number: 4970712982060
      • Ulm, Baden Wuerttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm
        • Principal Investigator:
          • Albert Christian Ludolph
        • Contact:
          • Phone Number: 497315000
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
        • Recruiting
        • Klinikum Bayreuth GmbH- Hohe Warte
        • Contact:
          • Phone Number: 499214003440
        • Principal Investigator:
          • Patrick Oschmann
      • München, Bayern, Germany, 81377
        • Recruiting
        • Klinikum der Universität München
        • Contact:
          • Phone Number: 4989440072570
        • Principal Investigator:
          • Guenter U Hoeglinger
    • Hessen
      • Erbach, Hessen, Germany, 64711
        • Recruiting
        • Neuro Centrum Science GmbH
        • Principal Investigator:
          • Gerd Reifschneider
        • Contact:
          • Phone Number: 496062941644
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Recruiting
        • Universitaetsmedizin Goettingen
        • Contact:
          • Phone Number: 495513966601
        • Principal Investigator:
          • Jens Wiltfang
    • Nordrhein Westfalen
      • Bonn, Nordrhein Westfalen, Germany, 53127
        • Recruiting
        • Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)
        • Contact:
          • Phone Number: 4922828715715
        • Principal Investigator:
          • Anja Schneider
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln
        • Contact:
          • Phone Number: 4922147832888
        • Principal Investigator:
          • Franziska Maier
    • Thueringen
      • Altenburg, Thueringen, Germany, 4600
        • Recruiting
        • Klinikum Altenburger Land GmbH
        • Principal Investigator:
          • Joerg Berrouschot
        • Contact:
          • Phone Number: 493447521316
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
        • Principal Investigator:
          • Alessandro Padovani
        • Contact:
          • Phone Number: 39303384086
      • Milano, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Phone Number: 390226435760
        • Principal Investigator:
          • Sandro Iannaccone
      • Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Contact:
          • Phone Number: 39223942177
        • Principal Investigator:
          • Pietro Tiraboschi
      • Perugia, Italy, 06156
        • Recruiting
        • Azienda Ospedaliera e Universitaria di Perugia
        • Principal Investigator:
          • Lucilla Parnetti
        • Contact:
          • Phone Number: 39755783545
      • Roma, Italy, 185
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
        • Principal Investigator:
          • Giuseppe Bruno
        • Contact:
          • Phone Number: 39649914604
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Recruiting
        • Azienda Ospedaliera Card. G. Panico
        • Contact:
          • Phone Number: 39805478536
        • Principal Investigator:
          • Giancarlo Logroscino
    • Palermo
      • Cefalù, Palermo, Italy, 90015
        • Recruiting
        • Fondazione Istituto G.Giglio di Cefalù
        • Contact:
          • Phone Number: 39921920470
        • Principal Investigator:
          • Luigi Grimaldi
    • Vicenza
      • Arzignano VI, Vicenza, Italy, 36071
        • Recruiting
        • Ospedale di Arzignano
        • Contact:
          • Phone Number: 39444753675
        • Principal Investigator:
          • Michela Marcon
  • Japan
    • Ehime-Ken
      • Toon-shi, Ehime-Ken, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital
    • Hyogo-Ken
      • Himeji-shi, Hyogo-Ken, Japan, 672-8043
        • Recruiting
        • Himeji Central Hospital Clinic
    • Kanagawa-Ken
      • Kawasaki-shi, Kanagawa-Ken, Japan, 211-8533
        • Recruiting
        • Nippon Medical School Musashi Kosugi Hospital
      • Yokohama-shi, Kanagawa-Ken, Japan, 231-8682
        • Recruiting
        • Yokohama City Minato Red Cross Hospital
    • Osaka-Fu
      • Osaka-shi, Osaka-Fu, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
      • Suita-shi, Osaka-Fu, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
    • Tokyo-To
      • Itabashi-ku, Tokyo-To, Japan, 173-0015
        • Recruiting
        • Tokyo Metropolitan Institute for Geriatrics and Gerontology
  • Netherlands
      • Amsterdam, Netherlands, Amsterdam
        • Recruiting
        • Brain Research Center Amsterdam
        • Principal Investigator:
          • Jort Vijverberg
        • Contact:
          • Phone Number: 31203017170
  • Poland
      • Bialystok, Poland, 15-756
        • Recruiting
        • Podlaskie Centrum Psychogeriatrii
        • Contact:
          • Phone Number: 48858745184
        • Principal Investigator:
          • Jacek Dobryniewski
      • Bydgoszcz, Poland, 85-133
        • Recruiting
        • PROMENTE Sp. z o.o.
        • Contact:
          • Phone Number: 48523485642
        • Principal Investigator:
          • Robert Kucharski
      • Katowice, Poland, 40-650
        • Recruiting
        • NZOZ Novo-Med
        • Principal Investigator:
          • Tomasz Jerzy Zielinski
        • Contact:
          • Phone Number: 48322030106
      • Katowice, Poland, 40568
        • Recruiting
        • Care Clinic Centrum Medyczne
        • Contact:
          • Phone Number: 48327894401
        • Principal Investigator:
          • Ewa Krzystanek
      • Krakow, Poland, 30-688
        • Recruiting
        • SPZOZ Szpital Uniwersytecki w Krakowie
        • Principal Investigator:
          • Agnieszka Slowik
        • Contact:
          • Phone Number: 48124248694
      • Lodz, Poland, 92-213
        • Recruiting
        • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
        • Contact:
          • Phone Number: 48426757372
        • Principal Investigator:
          • Jakub Kazmierski
      • Lublin, Poland, 20-954
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Kliniczny Oddział Neurologii Oddział Udarowy
        • Contact:
          • Phone Number: 48817244720
        • Principal Investigator:
          • Konrad Rejdak
      • Sopot, Poland, 81-855
        • Recruiting
        • Centrum Medyczne SENIOR
        • Principal Investigator:
          • Dorota Ussorowska
        • Contact:
          • Phone Number: 48604068142
      • Warszawa, Poland, 01-684
        • Recruiting
        • NeuroProtect Sp. z o.o.
        • Principal Investigator:
          • Maciej Czarnecki
        • Contact:
          • Phone Number: 48501762789
      • Warszawa, Poland, 03-242
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo
        • Contact:
          • Phone Number: 48223265815
        • Principal Investigator:
          • Dariusz Koziorowski
  • Spain
      • Barcelona, Spain, 8036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
          • Phone Number: 34934518240
        • Principal Investigator:
          • Albert Llado Plarrumani
      • Barcelona, Spain, 8025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Alberto Lleo Bisa
        • Contact:
          • Phone Number: 34935565986
      • Barcelona, Spain, 8028
        • Recruiting
        • Fundacio ACE
        • Principal Investigator:
          • Merce Boada Rovira
        • Contact:
          • Phone Number: 34934304720
      • Cordoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Principal Investigator:
          • Eduardo Aguera Morales
        • Contact:
          • Phone Number: 34688905848
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitari de Santa Maria
        • Contact:
          • Phone Number: 34973727366
        • Principal Investigator:
          • Gerard Pinol Ripoll
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Victoria Eugenia
        • Principal Investigator:
          • Felix Vinuela Fernandez
        • Contact:
          • Phone Number: 34654566812
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari I Politecnic La Fe
        • Contact:
          • Phone Number: 34961245542
        • Principal Investigator:
          • Miquel Baquero Toledo
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Dr. Peset
        • Principal Investigator:
          • Lamberto Landete Pascual
        • Contact:
          • Phone Number: 34961622300
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Mario Riverol Fernandez
        • Contact:
          • Phone Number: 34948255400
    • Vizcaya
      • Getxo, Vizcaya, Spain, 48993
        • Recruiting
        • CAE Oroitu
        • Contact:
          • Phone Number: 34946006568
        • Principal Investigator:
          • Manuel Fernandez Martinez
  • Sweden
      • Mölndal, Sweden, 43180
        • Recruiting
        • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
        • Principal Investigator:
          • Michael Jonsson
        • Contact:
          • Phone Number: 46313438667
      • Stockholm, Sweden, 14186
        • Recruiting
        • Karolinska universitetssjukhuset - Huddinge
        • Contact:
          • Phone Number: 46725981216
        • Principal Investigator:
          • Anne Borjesson Hanson
  • Switzerland
      • Biel/Bienne, Switzerland, 2501
        • Recruiting
        • Spitalzentrum Biel
        • Contact:
          • Phone Number: 41323244422
        • Principal Investigator:
          • Hans Pihan
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève - HUG- Centre de la mémoire, Bâtiment A1 - Morier
        • Contact:
          • Phone Number: 41223722983
        • Principal Investigator:
          • Giovanni Frisoni
    • Ticino
      • Lugano, Ticino, Switzerland, 6903
        • Recruiting
        • Ospedale Regionale di Lugano
        • Contact:
          • Phone Number: 41918116527
        • Principal Investigator:
          • Leonardo Sacco
  • United Kingdom
      • Bristol, United Kingdom, BS32 4SY
        • Recruiting
        • Re Cognition Health Bristol
        • Principal Investigator:
          • Daniel John Lashley
        • Contact:
          • Phone Number: 441752202082
    • Greater London
      • London, Greater London, United Kingdom, W1G 9RU
        • Recruiting
        • Re:Cognition Health Ltd (London)
        • Contact:
          • Phone Number: 442033553536
        • Principal Investigator:
          • Josephine MacSweeney
      • London, Greater London, United Kingdom, WC1N 3BG
        • Recruiting
        • The National Hospital for Neurology and Neurosurgery Centre
        • Principal Investigator:
          • Catherine Mummery
        • Contact:
          • Phone Number: 442034483011
      • London, Greater London, United Kingdom, SE5 8AF
        • Recruiting
        • Institute of Psychiatry, Psychology and Neuroscience
        • Principal Investigator:
          • Dag Aarsland
        • Contact:
          • Phone Number: 444751515151
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Principal Investigator:
          • Christopher Kipps
        • Contact:
          • Phone Number: 442381205434
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Recruiting
        • Warneford Hospital
        • Principal Investigator:
          • Vanessa Raymont
        • Contact:
          • Phone Number: 442084831827
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Royal Hallamshire Hospital
        • Contact:
          • Phone Number: 441142713339
        • Principal Investigator:
          • Ronan O Malley
    • Strathclyde
      • Motherwell, Strathclyde, United Kingdom, ML1 4UF
        • Recruiting
        • NeuroClin Limited
        • Contact:
          • Phone Number: 441419480206
        • Principal Investigator:
          • Jennifer Lynch
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B16 8LT
        • Recruiting
        • Re:Cognition Health - Birmingham
        • Principal Investigator:
          • Conor Clerkin-Oliver
        • Contact:
          • Phone Number: 441216550166
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Xenoscience Inc.
        • Principal Investigator:
          • Stephen S Flitman
        • Contact:
          • Phone Number: 602-274-9500
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • HonorHealth Neurology
        • Principal Investigator:
          • Todd Levine
        • Contact:
          • Phone Number: 602-658-2863
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Banner Sun Health Research Institute
        • Contact:
          • Phone Number: 623-832-6500
        • Principal Investigator:
          • Parichita Choudhury
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Center for Neurosciences
        • Contact:
          • Phone Number: 520-529-5234
        • Principal Investigator:
          • Michael Badruddoja
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Mary S. Easton Center for Alzheimer's Disease Research, UCLA
        • Contact:
          • Phone Number: 310-794-6191
        • Principal Investigator:
          • Maryam Rezagholi Beigi
      • Orange, California, United States, 92868
        • Recruiting
        • PNS Clinical Research, LLC dba
        • Principal Investigator:
          • Gustavo Alva
        • Contact:
          • Phone Number: 714-277-4472
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Hospital and Clinics
        • Contact:
          • Phone Number: 617-732-0885
        • Principal Investigator:
          • Irina Skylar-Scott
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Institute for Medical Research
        • Contact:
          • Phone Number: 916-454-6850
        • Principal Investigator:
          • Shawn Kile
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco (PARENT)
        • Contact:
          • Phone Number: 415-353-2557
        • Principal Investigator:
          • Lawren VandeVrede
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Rocky Mountain Movement Disorders Center, PC
        • Principal Investigator:
          • Rajeev Kumar
        • Contact:
          • Phone Number: 303-357-5455
    • Florida
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • Charter Research, LLC
        • Contact:
          • Phone Number: 352-775-1000
        • Principal Investigator:
          • Jeffrey Norton
      • Orlando, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research, LLC
        • Contact:
          • Phone Number: 407-670-5833
        • Principal Investigator:
          • Sheila Baez-Torres
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health
        • Principal Investigator:
          • Anwar Ahmed
        • Contact:
          • Phone Number: 407-303-6729
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Contact:
          • Phone Number: 407-636-4031
        • Principal Investigator:
          • Malisa Agard
      • Winter Park, Florida, United States, 32792
        • Recruiting
        • Charter Research, LLC
        • Contact:
          • Phone Number: 407-801-8400
        • Principal Investigator:
          • Edgardo Rivera Rivera
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience
        • Principal Investigator:
          • Kore Liow
        • Contact:
          • Phone Number: 808-564-6141
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5804
        • Recruiting
        • Brigham and Women's Hospital Department of Neurology
        • Contact:
          • Phone Number: 617-732-8085
        • Principal Investigator:
          • Scott M. McGinnis
      • Boston, Massachusetts, United States, 02216
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Phone Number: 617-667-0459
        • Principal Investigator:
          • Daniel Z. Press
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Clinic Medical Center - Burlington
        • Contact:
          • Phone Number: 781-744-8630
        • Principal Investigator:
          • Oleg Yerstein
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Boston Center for Memory
        • Contact:
          • Phone Number: 617-699-6927
        • Principal Investigator:
          • Paul R Solomon
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Neurological Associates of Albany, PC
        • Contact:
          • Phone Number: 518-449-2662
        • Principal Investigator:
          • Richard F Holub
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute
        • Contact:
          • Phone Number: 716-250-2000
        • Principal Investigator:
          • Bela Ajtai
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Medical Center PRIME
        • Principal Investigator:
          • Martin Joseph Sadowski
        • Contact:
          • Phone Number: 516-470-6901
      • Patchogue, New York, United States, 11772
        • Recruiting
        • South Shore Neurologic Associates, P.C.
        • Principal Investigator:
          • Mark Gudesblatt
        • Contact:
          • Phone Number: 63175819102246
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
          • Phone Number: 301-520-5549
        • Principal Investigator:
          • Tinatin Chabrashvili
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
          • Phone Number: 919-660-3234
        • Principal Investigator:
          • Andy Liu
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • AMC Research, LLC
        • Contact:
          • Phone Number: 225 704-364-4000
        • Principal Investigator:
          • Mohammad Reza Bolouri
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • NeuroScience Research Center, LLC.
        • Principal Investigator:
          • Ryan Drake
        • Contact:
          • Phone Number: 330-244-2542
      • Cincinnati, Ohio, United States, 45206-0829
        • Recruiting
        • University of Cincinnati Physicians Group, LLC
        • Contact:
          • Phone Number: 513-558-2634
        • Principal Investigator:
          • Russell Sawyer
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Butler Hospital
        • Principal Investigator:
          • Meghan Riddle
        • Contact:
          • Phone Number: 401-455-6403
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, PC
        • Principal Investigator:
          • Lee Stein
        • Contact:
          • Phone Number: 901-866-9252
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Neurology Consultants of Dallas, PA
        • Principal Investigator:
          • Duc Tran
        • Contact:
          • Phone Number: 293 214-750-9977
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
          • Phone Number: 210-450-9600
        • Principal Investigator:
          • Arash Salardini
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • EvergreenHealth
        • Contact:
          • Phone Number: 425-899-3123
        • Principal Investigator:
          • Daniel Josiah Burdick
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Kingfisher Cooperative, LLC
        • Contact:
          • Phone Number: 509-747-5615
        • Principal Investigator:
          • David Greeley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

  • 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.
  • MMSE score >10 at the Week 76 visit.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Q12W
Participants 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 long-term extension (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.
Drug: BIIB080-matching placebo
Administered as specified in the treatment arm.
Drug: BIIB080
Administered as specified in the treatment arm.
Other Names:
  • ISIS 814907
Experimental: BIIB080 Low Dose Q24W
Participants 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.
Drug: BIIB080-matching placebo
Administered as specified in the treatment arm.
Drug: BIIB080
Administered as specified in the treatment arm.
Other Names:
  • ISIS 814907
Experimental: BIIB080 High Dose Q24W
Participants 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.
Drug: BIIB080-matching placebo
Administered as specified in the treatment arm.
Drug: BIIB080
Administered as specified in the treatment arm.
Other Names:
  • ISIS 814907
Experimental: BIIB080 High Dose Q12W
Participants 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.
Drug: BIIB080
Administered as specified in the treatment arm.
Other Names:
  • ISIS 814907

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose response in Change From Baseline to Week 76 on the CDR-SB
Time Frame: Baseline to Week 76
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 76 on the CDR-SB
Time Frame: Baseline to Week 76
The 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. Positive change from baseline indicates clinical decline.
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)
Time Frame: Baseline to Week 76
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the participant's actual functioning and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. Positive change from baseline indicates clinical improvement.
Baseline to Week 76
Change From Baseline to Week 76 on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 13)
Time Frame: Baseline to Week 76
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. Positive change from baseline indicates clinical decline.
Baseline to Week 76
Change From Baseline to Week 76 on the Mini Mental State Examination (MMSE)
Time Frame: Baseline to Week 76
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. Positive change from baseline indicates clinical improvement.
Baseline to Week 76
Change From Baseline to Week 76 on the Modified Integrated Alzheimer's Disease Rating Scale (iADRS)
Time Frame: Baseline to Week 76
iADRS is a composite and is calculated as a linear combination of total scores of ADAS-Cog13 and Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) that measures cognition and daily function. ADCS-iADL is calculated from a subset of questions from ADCS-ADL. Range for ADCS-iADL is 0-59 and higher scores reflect better performance. ADAS-Cog13 comprises cognitive tasks and clinical ratings of cognitive performance. Scale items capture word recall, ability to follow commands, ability to correctly copy/draw, naming, ability to interact with everyday objects, orientation, word recognition, memory, spoken language comprehension, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. Score ranges from 0 to 85 with higher scores reflecting cognitive impairment. iADRS score range is 0-144 and higher scores indicate greater impairment. Positive change from baseline indicates clinical decline.
Baseline to Week 76
Change From Baseline to Week 76 on the Alzheimer's Disease Composite Score (ADCOMS)
Time Frame: Baseline to Week 76
ADCOMS is a composite score comprised of ADAS-cog (4 items), MMSE (2 items) and CDR-SB (6 items). The total scores on the scale range from 0 to 1.97 with higher scores indicating greater impairment. Positive change from baseline indicates clinical decline.
Baseline to Week 76
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose of study drug up to end of study of placebo-controlled period (up to Week 96)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. TEAE is any AE that started or worsened on or after the administration of the first dose of study drug through the end of follow-up period. SAE is any untoward medical occurrence that at any dose results in death, in the view of investigator, places the participant at immediate risk of death (life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or is medically important event.
From first dose of study drug up to end of study of placebo-controlled period (up to Week 96)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Estimated)

November 19, 2027

Study Completion (Estimated)

February 4, 2030

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 247AD201
  • 2022-501644-15 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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