AzTrials
AzTrials

Mild Cognitive Impairment Due to Alzheimer's DiseasePhase 2CELIANCT05399888

A Study to Learn About the Safety of Diranersen (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

A Phase 2 study testing Diranersen in people with Mild Cognitive Impairment Due to Alzheimer's Disease and Alzheimer's Disease Dementia, run by Biogen at 138 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In this study, researchers will learn more about a study drug called diranersen (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 diranersen can slow the worsening of AD more than placebo. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
Diranersen
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
138 sitesin 17 countries
Study dates
24 Aug 2022to 6 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

138 sites in 17 countries.

138 sites in 17 countries

United States36 sites

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts, 02115-5804

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02216

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • NeuroScience Research Center, LLC.

    Canton, Ohio, 44718

  • University of Cincinnati Physicians Group, LLC

    Cincinnati, Ohio, 45206-0829

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243

  • Duke University

    Durham, North Carolina, 27710

  • Rocky Mountain Movement Disorders Center, PC

    Englewood, Colorado, 80113

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • EvergreenHealth

    Kirkland, Washington, 98034

  • Charter Research, LLC

    Lady Lake, Florida, 32159

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

    Los Angeles, California, 90095

  • AMC Research, LLC

    Matthews, North Carolina, 28105

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • PNS Clinical Research, LLC dba

    Orange, California, 92868

  • K2 Medical Research, LLC

    Orlando, Florida, 32751

  • Advent Health

    Orlando, Florida, 32804

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • South Shore Neurologic Associates, P.C.

    Patchogue, New York, 11772

  • Xenoscience Inc.

    Phoenix, Arizona, 85004

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • University of California San Francisco (PARENT)

    San Francisco, California, 94143

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251

  • Kingfisher Cooperative, LLC

    Spokane, Washington, 99202

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Conquest Research

    Winter Park, Florida, 32789

  • Charter Research, LLC

    Winter Park, Florida, 32792

Other trials in United States

Germany13 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 4600

  • Klinikum Bayreuth GmbH- Hohe Warte

    Bayreuth, Bavaria, 95445

  • Charité - Campus Charité Mitte

    Berlin, 10117

  • Charité - Universitätsmedizin Berlin

    Berlin, 13125

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791

  • Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Neuro Centrum Science GmbH

    Erbach im Odenwald, Hesse, 64711

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075

  • Universitaetsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum der Universität München

    München, Bavaria, 81377

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

United Kingdom11 sites

  • Re:Cognition Health - Birmingham

    Birmingham, West Midlands, B16 8LT

  • Re Cognition Health Bristol

    Bristol, BS32 4SY

  • Institute of Psychiatry, Psychology and Neuroscience

    London, Greater London, SE5 8AF

  • Re:Cognition Health Ltd (London)

    London, Greater London, W1G 9RU

  • Charing Cross Hospital

    London, Greater London, W6 8RF

  • The National Hospital for Neurology and Neurosurgery Centre

    London, Greater London, WC1N 3BG

  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester, Greater Manchester, M13 9WL

  • NeuroClin Limited

    Motherwell, Strathclyde, ML1 4UF

  • Warneford Hospital

    Oxford, Oxfordshire, OX3 7JX

  • Royal Hallamshire Hospital

    Sheffield, South Yorkshire, S10 2JF

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Poland10 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • PROMENTE Sp. z o.o.

    Bydgoszcz, 85-133

  • Nzoz Novo-Med

    Katowice, 40-650

  • Care Clinic Centrum Medyczne

    Katowice, 40568

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92-213

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

    Lublin, 20-954

  • Centrum Medyczne Senior

    Sopot, 81-855

  • NeuroProtect Sp. z o.o.

    Warsaw, 01-684

  • Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

    Warsaw, 03-242

Other trials in Poland

Spain10 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Fundacio ACE

    Barcelona, 8028

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • CAE Oroitu

    Getxo, Vizcaya, 48993

  • Hospital Universitari de Santa Maria

    Lleida, 25198

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Victoria Eugenia

    Seville, 41009

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France9 sites

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295

  • Hôpital Lariboisière

    Paris, Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, Seine Maritime, 76031

  • CHU Nantes - Hopital Nord Laënnec

    Saint-Herblain, Loire Atlantique, 44800

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67000

  • Hopital Purpan

    Toulouse, Haute Garonne, 31059

  • Hôpital La Grave

    Toulouse, Haute Garonne, 31059

Other trials in France

Canada8 sites

  • Clinique de la Memoire de l'Outaouais

    Gatineau, Quebec, J8T 8J1

  • The Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 5T1

  • Montreal Neurological Institute Clinical Research Unit

    Montreal, Quebec, H3A 2B4

  • Jewish General Hospital - NETWORK

    Montreal, Quebec, H3T 1E2

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

    Ottawa, Ontario, K1Z 1G3

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • UBC Hospital

    Vancouver, British Columbia, V6T 2B5

  • Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T 1C5

Other trials in Canada

Italy8 sites

  • Ospedale di Arzignano

    Arzignano VI, Vicenza, 36071

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

    Brescia, 25123

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • Azienda Ospedaliera e Universitaria di Perugia

    Perugia, 06156

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

    Roma, 185

  • Azienda Ospedaliera Card. G. Panico

    Tricase, Lecce, 73039

Other trials in Italy

Japan7 sites

  • Himeji Central Hospital Clinic

    Himeji-shi, Hyōgo, 672-8043

  • Nippon Medical School Musashi Kosugi Hospital

    Kawasaki-shi, Kanagawa, 211-8533

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    tabashi City, Tokyo-To, 173-0015

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682

Other trials in Japan

Czechia6 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni nemocnice Ostrava

    Ostrava, 70852

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • FORBELI s.r.o.

    Prague, 16000

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Australia5 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Belgium4 sites

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Switzerland4 sites

  • Spitalzentrum Biel

    Biel/Bienne, 2501

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

    Geneva, 1205

  • Ospedale Regionale di Lugano

    Lugano, Canton Ticino, 6903

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Denmark2 sites

  • Ålborg Universitets Hospital

    Aalborg, 9100

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Finland2 sites

  • Itä-Suomen yliopisto, Kuopion kampus

    Kuopio, 70210

  • CRST, Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, 43180

  • Karolinska universitetssjukhuset - Huddinge

    Stockholm, 14186

Other trials in Sweden

Netherlands1 site

  • Brain Research Center Amsterdam

    Amsterdam, Amsterdam

Other trials in Netherlands

About this study

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

In this study, researchers will learn more about a study drug called diranersen (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 diranersen can slow the worsening of AD more than placebo. It will focus on what dose of diranersen slows worsening of AD the most.

Read more

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 diranersen.

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 diranersen, 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 diranersen, 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 diranersen 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 diranersen 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.
Read the detailed description

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

Being tested
Diranersen, Diranersen-matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiranersenDrug

    Also called ISIS 814907, BIIB080

    Administered as specified in the treatment arm.

  • Diranersen-matching placeboDrug

    Administered as specified in the treatment arm.

Study groups in NCT05399888
Study groupRoleWhat they receive
Placebo Q12WPlacebo comparatorParticipants will receive diranersen-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 diranersen high dose, IT injection, either Q12W or once every 24 weeks (Q24W) for an additional 96 weeks.
Receives: Drug: Diranersen; Drug: Diranersen-matching placebo
Diranersen Low Dose Q24WExperimentalParticipants will receive a low dose of diranersen, IT injection, Q24W from Week 1 up to 72 weeks and diranersen-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 diranersen low dose, IT injection, Q24W for an additional 96 weeks.
Receives: Drug: Diranersen; Drug: Diranersen-matching placebo
Diranersen High Dose Q24WExperimentalParticipants will receive a high dose of diranersen, IT injection, Q24W from Week 1 up to 72 weeks and diranersen-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 diranersen high dose, IT injection, Q24W for an additional 96 weeks.
Receives: Drug: Diranersen; Drug: Diranersen-matching placebo
Diranersen High Dose Q12WExperimentalParticipants will receive a high dose of diranersen, 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 diranersen high dose, IT injection, Q12W for an additional 96 weeks.
Receives: Drug: Diranersen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 76

Secondary outcomes (7)

  1. Change From Baseline to Week 76 on the CDR-SB

    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.

    Measured: Baseline to Week 76

  2. Change From Baseline to Week 76 on the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI)

    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.

    Measured: Baseline to Week 76

  3. Change From Baseline to Week 76 on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog 13)

    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.

    Measured: Baseline to Week 76

  4. Change From Baseline to Week 76 on the Mini Mental State Examination (MMSE)

    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.

    Measured: Baseline to Week 76

  5. Change From Baseline to Week 76 on the Modified Integrated Alzheimer's Disease Rating Scale (iADRS)

    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.

    Measured: Baseline to Week 76

  6. Change From Baseline to Week 76 on the Alzheimer's Disease Composite Score (ADCOMS)

    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.

    Measured: Baseline to Week 76

  7. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From first dose of study drug up to end of study of placebo-controlled period (up to Week 96)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start24 Aug 2022
  3. Primary completion11 Mar 2026
  4. Study completion6 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05399888
Sponsor's protocol ID
247AD201
Other IDs
2022-501644-15
Acronym
CELIA
Status last verified
Jun 2026
First submitted
27 May 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diranersen in people with Mild Cognitive Impairment Due to Alzheimer's Disease and Alzheimer's Disease Dementia, run by Biogen at 138 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Germany, United Kingdom, Poland, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose response in Change From Baseline to Week 76 on the CDR-SB (time frame: Baseline to Week 76). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05399888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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