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Could a spinal injection slow Alzheimer's? new trial underway

NCT ID NCT05399888

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This Phase 2 study tests an experimental drug called BIIB080 in people with mild cognitive impairment or mild dementia due to Alzheimer's disease. The drug is injected into the fluid around the spinal cord every 12 or 24 weeks. Researchers want to see if it can slow the worsening of symptoms compared to a placebo. The study involves 416 participants and lasts about 4 years, including a long-term extension where everyone can receive the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BIIB080 (a drug injected into the fluid around the spinal cord)
What this could lead to
If it works, this could point toward a treatment that slows the worsening of Alzheimer's symptoms, helping people stay independent longer.
What could go wrong
This is an early Phase 2 trial, so results may not confirm benefit. The drug is injected into the spine, which carries risks like headache or infection. It may not slow the disease at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

416 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 diranersen 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 diranersen or a history of hypersensitivity to any of the inactive ingredients in the drug product. * Previous participation in this study or previous studies with diranersen. * 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease dementia Mild cognitive impairment due to Alzheimer's disease

Contacts and locations

Locations

  • AMC Research, LLC

    Matthews, North Carolina, 28105, United States

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • Advent Health

    Orlando, Florida, 32804, United States

  • Azienda Ospedaliera Card. G. Panico

    Tricase, Lecce, 73039, Italy

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

    Roma, 185, Italy

  • Azienda Ospedaliera e Universitaria di Perugia

    Perugia, 06156, Italy

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

    Brescia, 25123, Italy

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02216, United States

  • Boston Center for Memory

    Newton, Massachusetts, 02459, United States

  • Brain Research Center Amsterdam

    Amsterdam, Amsterdam, Netherlands

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts, 02115-5804, United States

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

  • CAE Oroitu

    Getxo, Vizcaya, 48993, Spain

  • CHU Nantes - Hopital Nord Laënnec

    Saint-Herblain, Loire Atlantique, 44800, France

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67000, France

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, Seine Maritime, 76031, France

  • CRST, Clinical Research Services Turku

    Turku, 20520, Finland

  • Care Clinic Centrum Medyczne

    Katowice, 40568, Poland

  • Center for Neurosciences

    Tucson, Arizona, 85718, United States

  • Centrum Medyczne Senior

    Sopot, 81-855, Poland

  • Charing Cross Hospital

    London, Greater London, W6 8RF, United Kingdom

  • Charité - Campus Charité Mitte

    Berlin, 10117, Germany

  • Charité - Universitätsmedizin Berlin

    Berlin, 13125, Germany

  • Charter Research, LLC

    Lady Lake, Florida, 32159, United States

  • Charter Research, LLC

    Winter Park, Florida, 32792, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinique de la Memoire de l'Outaouais

    Gatineau, Quebec, J8T 8J1, Canada

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Duke University

    Durham, North Carolina, 27710, United States

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295, Japan

  • EvergreenHealth

    Kirkland, Washington, 98034, United States

  • FORBELI s.r.o.

    Prague, 16000, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava, 70852, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015, Italy

  • Fundacio ACE

    Barcelona, 8028, Spain

  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013, France

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817, United States

  • Himeji Central Hospital Clinic

    Himeji-shi, Hyōgo, 672-8043, Japan

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251, United States

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295, France

  • Hopital Purpan

    Toulouse, Haute Garonne, 31059, France

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037, France

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Universitari de Santa Maria

    Lleida, 25198, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Victoria Eugenia

    Seville, 41009, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025, Spain

  • Hôpital La Grave

    Toulouse, Haute Garonne, 31059, France

  • Hôpital Lariboisière

    Paris, Paris, 75010, France

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

    Geneva, 1205, Switzerland

  • Institute of Psychiatry, Psychology and Neuroscience

    London, Greater London, SE5 8AF, United Kingdom

  • Itä-Suomen yliopisto, Kuopion kampus

    Kuopio, 70210, Finland

  • Jewish General Hospital - NETWORK

    Montreal, Quebec, H3T 1E2, Canada

  • K2 Medical Research, LLC

    Orlando, Florida, 32751, United States

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Karolinska universitetssjukhuset - Huddinge

    Stockholm, 14186, Sweden

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791, Germany

  • Kingfisher Cooperative, LLC

    Spokane, Washington, 99202, United States

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 4600, Germany

  • Klinikum Bayreuth GmbH- Hohe Warte

    Bayreuth, Bavaria, 95445, Germany

  • Klinikum der Universität München

    München, Bavaria, 81377, Germany

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805, United States

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

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

    Los Angeles, California, 90095, United States

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101, Australia

  • Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

    Warsaw, 03-242, Poland

  • Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T 1C5, Canada

  • Montreal Neurological Institute Clinical Research Unit

    Montreal, Quebec, H3A 2B4, Canada

  • Neuro Centrum Science GmbH

    Erbach im Odenwald, Hesse, 64711, Germany

  • NeuroClin Limited

    Motherwell, Strathclyde, ML1 4UF, United Kingdom

  • NeuroProtect Sp. z o.o.

    Warsaw, 01-684, Poland

  • NeuroScience Research Center, LLC.

    Canton, Ohio, 44718, United States

  • Neurological Associates of Albany, PC

    Albany, New York, 12208, United States

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018, United States

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243, United States

  • New York University Medical Center PRIME

    New York, New York, 10016, United States

  • Nippon Medical School Musashi Kosugi Hospital

    Kawasaki-shi, Kanagawa, 211-8533, Japan

  • Nzoz Novo-Med

    Katowice, 40-650, Poland

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871, Japan

  • Ospedale Regionale di Lugano

    Lugano, Canton Ticino, 6903, Switzerland

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Ospedale di Arzignano

    Arzignano VI, Vicenza, 36071, Italy

  • PNS Clinical Research, LLC dba

    Orange, California, 92868, United States

  • PROMENTE Sp. z o.o.

    Bydgoszcz, 85-133, Poland

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756, Poland

  • Re Cognition Health Bristol

    Bristol, BS32 4SY, United Kingdom

  • Re:Cognition Health - Birmingham

    Birmingham, West Midlands, B16 8LT, United Kingdom

  • Re:Cognition Health Ltd (London)

    London, Greater London, W1G 9RU, United Kingdom

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

    Ottawa, Ontario, K1Z 1G3, Canada

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Rocky Mountain Movement Disorders Center, PC

    Englewood, Colorado, 80113, United States

  • Royal Hallamshire Hospital

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92-213, Poland

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, 43180, Sweden

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

    Lublin, 20-954, Poland

  • South Shore Neurologic Associates, P.C.

    Patchogue, New York, 11772, United States

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • Southern Neurology

    Kogarah, New South Wales, 2217, Australia

  • Spitalzentrum Biel

    Biel/Bienne, 2501, Switzerland

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304, United States

  • Sutter Institute for Medical Research

    Sacramento, California, 95816, United States

  • The Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 5T1, Canada

  • The National Hospital for Neurology and Neurosurgery Centre

    London, Greater London, WC1N 3BG, United Kingdom

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Itabashi-ku, Tokyo-To, 173-0015, Japan

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7, Canada

  • UBC Hospital

    Vancouver, British Columbia, V6T 2B5, Canada

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075, Germany

  • Universitaetsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • 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

  • University of Cincinnati Physicians Group, LLC

    Cincinnati, Ohio, 45206-0829, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01, Czechia

  • Warneford Hospital

    Oxford, Oxfordshire, OX3 7JX, United Kingdom

  • Xenoscience Inc.

    Phoenix, Arizona, 85004, United States

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682, Japan

  • Ålborg Universitets Hospital

    Aalborg, 9100, Denmark

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