A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants with Early Alzheimer's Disease (ALTITUDE-AD)

Last updated: December 17, 2024
Sponsor: Acumen Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

sabirnetug

ACU193

Placebo

Clinical Study ID

NCT06335173
ACU193-201
2023-509807-34-00
  • Ages 50-90
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body weight of at least 30 kilograms (kg) (66 pounds [lbs]) and no more than 160 kg (352 lbs) at Screening

  • Must consent to apolipoprotein E4 (APOE4) genotype status assessment

  • Must meet all of the following criteria

  1. National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mildcognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD

  2. Screening score between 22 and 30 (inclusive) on the Mini-Mental StateExamination (MMSE)

  3. Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score

  4. Evidence of cerebral amyloid accumulation by either PET scan or CSF

  • If using cholinesterase inhibitors or memantine to treat symptoms related to AD,doses must be stable for at least three months (12 weeks) prior to Baseline andevery attempt should be made to keep them at stable doses throughout the study

  • Must have a reliable informant or study partner who is willing and able to performall the roles as specified in the study partner Informed Consent Form (ICF)

  • Female participants must be surgically sterile or be at least one-yearpost-menopausal. Male participants with a female partner of child-bearing potentialmust use adequate contraception

Exclusion

Exclusion Criteria:

  • Has any contraindications for MRI studies, including claustrophobia, the presence ofmetal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible withMRI

  • MRI of the brain that is inconsistent with MCI or AD or results showing greater thanfour ARIA-H, presence of any ARIA-E, or superficial siderosis

  • History of significant or unstable neurological disease, other than AD, which mayaffect cognition or ability to complete the study, such as other dementias, seriousinfection of the brain, significant head trauma, uncontrolled seizures, stroke, orParkinson´s disease

  • Current serious or unstable clinically important illness that, in the judgment ofthe site investigator, is likely to affect cognitive assessment including visual andhearing impairment or affect the participant's safety or ability to complete thestudy

  • Malignant disease in the last five years except for resected cutaneous squamous cellcarcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situprostate cancer with a normal posttreatment prostate-specific antibody (PSA)

  • Geriatric Depression Scale-Short Form (GDS-SF) score >10 or current symptoms meetingDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V),criteria for major depressive disorder or any current primary psychiatric diagnosisother than AD if, in the judgment of the site investigator, the psychiatric disorderor symptom is likely to confound interpretation of drug effect, affect cognitiveassessments, or affect the participant´s ability to complete the study

  • Suicide risk, as determined by meeting any of the following criteria:

  1. Any suicide attempt or preparatory acts/behavior on the C-SSRSBaseline/Screening in the last six months

  2. Suicidal ideation in the last six months as defined by a positive response toQuestion 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening

  3. Significant risk of suicide, as judged by the site investigator

  • Conditions that may affect cognitive assessments during the study

  • Alcohol use disorder and/or substance use disorder within the last five years

Study Design

Total Participants: 540
Treatment Group(s): 3
Primary Treatment: sabirnetug
Phase: 2
Study Start date:
February 29, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Okanagan Clinical Trials

    Kelowna, British Columbia
    Canada

    Site Not Available

  • Office of Alexandre Henri-Bhargava, MD

    Victoria, British Columbia
    Canada

    Site Not Available

  • Parkwood Institute

    London, Ontario
    Canada

    Site Not Available

  • Hippocampe d/b/a Ottawa Memory Clinic

    Ottawa, Ontario
    Canada

    Site Not Available

  • The Kawartha Regional Memory Clinic (KRMC)

    Peterborough, Ontario
    Canada

    Site Not Available

  • Baycrest - The Rotman Research Institute (RRI)

    Toronto, Ontario
    Canada

    Site Not Available

  • Toronto Memory Program (TMP) (Neurology Research Inc.)

    Toronto, Ontario
    Canada

    Site Not Available

  • University Health Network (UHN) - Toronto Western Hospital (TWH) - Krembil Neuroscience Centre (KNC) - Memory Clinic

    Toronto, Ontario
    Canada

    Site Not Available

  • MoCA Research and Innovations

    Greenfield Park, Quebec
    Canada

    Site Not Available

  • Amiens university hospital

    Amiens,
    France

    Site Not Available

  • Chu Pellegrin

    Bordeaux,
    France

    Site Not Available

  • Hopital Neurologique Pierre Wertheimer

    Bron,
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille Cedex 05,
    France

    Site Not Available

  • Chu Montpellier

    Montpellier,
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris,
    France

    Site Not Available

  • Institut de la Mémoire et de la Maladie d'Alzheimer -IM2A

    Paris,
    France

    Site Not Available

  • CHU de Rennes, CMRR

    Rennes,
    France

    Site Not Available

  • CHU de NANTES-Hôpital Nord Laennec

    Saint-Herblain,
    France

    Site Not Available

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave

    Toulouse,
    France

    Site Not Available

  • Charité - Universitaetsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Chemnitz,
    Germany

    Site Not Available

  • University Hospital of Cologne

    Cologne,
    Germany

    Site Not Available

  • Saarland University Hospital

    Homburg,
    Germany

    Site Not Available

  • Zentralinstitut für seelische Gesundheit

    Mannheim,
    Germany

    Site Not Available

  • Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar

    Munich,
    Germany

    Site Not Available

  • Rostock University Medical Center

    Rostock,
    Germany

    Site Not Available

  • Praxisgemeinschaft Dr. Springub/Schwarz

    Westerstede,
    Germany

    Site Not Available

  • Fondazione Istituto G. Giglio di Cefalù

    Cefalù,
    Italy

    Site Not Available

  • Policlinico San Martino

    Genova,
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano,
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza,
    Italy

    Site Not Available

  • Neurology Clinic

    Perugia,
    Italy

    Site Not Available

  • IRCCS Neuromed

    Pozzilli,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma,
    Italy

    Site Not Available

  • Sapienza Università di Roma - AOU Policlinico Umberto I

    Roma,
    Italy

    Site Not Available

  • SSD Alzheimer's disease and related dementias

    Torino,
    Italy

    Site Not Available

  • A.O. Piafondazione Card. G. Panico

    Tricase,
    Italy

    Site Not Available

  • Centrum Medyczne Neuromed

    Bydgoszcz,
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow,
    Poland

    Site Not Available

  • NZOZ Syntonia

    Pruszcz Gdanski,
    Poland

    Site Not Available

  • RCMed

    Sochaczew,
    Poland

    Site Not Available

  • Centrum Medyczne Senior

    Sopot,
    Poland

    Site Not Available

  • Centrum Medyczne NeuroProtect

    Warsaw,
    Poland

    Site Not Available

  • Hospital Universitari General de catalunya

    Sant Cugat Del Vallès, Barcelona
    Spain

    Site Not Available

  • Fundacion CITA alzheimer

    San Sebastián, Gipuzkoa
    Spain

    Site Not Available

  • Fundacion Neuropolis - Hospital Viamed Montecanal

    Cuarte de Huerva, Zaragoza
    Spain

    Site Not Available

  • Fundacio ACE

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba,
    Spain

    Site Not Available

  • Cae Oroitu

    Getxo,
    Spain

    Site Not Available

  • Hospital Ruber

    Madrid,
    Spain

    Site Not Available

  • Policlínica Gipuzkoa

    San Sebastian,
    Spain

    Site Not Available

  • Hospital Victoria Eugenia

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia,
    Spain

    Site Not Available

  • Re:Cognition Health - Plymouth

    Plymouth, Devon
    United Kingdom

    Site Not Available

  • Panthera Biopartners - Enfield

    Enfield Town, Greater London
    United Kingdom

    Site Not Available

  • Re:Cognition Health - London

    London, Greater London
    United Kingdom

    Site Not Available

  • St. Pancras Clinical Research Ltd.

    London, Greater London
    United Kingdom

    Site Not Available

  • Panthera Bio-Partners - Rochdale

    Rochdale, Greater Manchester
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Winchester

    Winchester, Hampshire
    United Kingdom

    Site Not Available

  • Neuroclin Glasgow

    Motherwell, Lanarkshire
    United Kingdom

    Site Not Available

  • Panthera Bio-Partners - Preston

    Preston, Lancashire
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Guildford

    Guildford, Surrey
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Birmingham

    Birmingham, West Midlands
    United Kingdom

    Site Not Available

  • Panthera Biopartners - Sheffield

    Sheffield, Yorkshire
    United Kingdom

    Site Not Available

  • Re:Cognition Health - Bristol

    Bristol,
    United Kingdom

    Site Not Available

  • Banner Alzheimer's Institute- Clinical Trials Department

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • IMA Clinical Research - Phoenix

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • The Neurology Center of Southern California - Carlsbad

    Carlsbad, California 92011-4219
    United States

    Site Not Available

  • Neurology Center of North Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Irvine Medical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Healthy Brain Research

    Long Beach, California 90804
    United States

    Site Not Available

  • Sharp Mesa Vista Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • CenExel - California Neuroscience Research Medical Group, Inc (CNR)

    Sherman Oaks, California 91403-2131
    United States

    Site Not Available

  • Alpine Clinical Research Center

    Boulder, Colorado 80301-1880
    United States

    Site Not Available

  • The Mile High Research Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU)

    New Haven, Connecticut 06510-3330
    United States

    Site Not Available

  • Research Center for Clinical Studies, LLC

    Norwalk, Connecticut 06851-4903
    United States

    Site Not Available

  • Re:Cognition Health - Fairfax

    Washington, District of Columbia 22031
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Bradenton Research Center

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Gil Fernandez-Yera, MD, PA

    Coral Gables, Florida 33135
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Coral Clinical Research

    Homestead, Florida 33032
    United States

    Site Not Available

  • K2 Medical Research - Villages

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Finlay Medical Research

    Miami, Florida 33126
    United States

    Site Not Available

  • Verus Clinical Research

    Miami, Florida 33125
    United States

    Site Not Available

  • Collier Neurologic Specialists (CNS), L.L.C.

    Naples, Florida 34105-8522
    United States

    Site Not Available

  • Ocala Health - Family Care Specialists - Ocala I

    Ocala, Florida 34470
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center - Stuart

    Stuart, Florida 34997
    United States

    Site Not Available

  • K2 Medical Research - Tampa

    Tampa, Florida 33607
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Site Not Available

  • Alzheimers Research and Treatment Center - Wellington

    Wellington, Florida 33414
    United States

    Site Not Available

  • Charter Research - Winter Park

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Columbus Memory Center

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Accel Research- Neurostudies

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CenExel - iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CenExel - iResearch Savannah

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Office of Jeffrey S. Ross, MD

    Northbrook, Illinois 60640
    United States

    Site Not Available

  • KU Wichita Center for Clinical Research

    Wichita, Kansas 67214
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 03801
    United States

    Site Not Available

  • Boston Center for Memory

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Donald S. Marks, MD. P.C.

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Hattiesburg Clinic - Memory Center

    Hattiesburg, Mississippi 39401-7246
    United States

    Site Not Available

  • Las Vegas Medical Research Center

    Las Vegas, Nevada 89113-2215
    United States

    Site Not Available

  • ActivMed Practices and Research

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Princeton Psychiatric Center

    Princeton, New Jersey 08540-2859
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Site Not Available

  • CenExel - Advanced Memory Research Institute of NJ

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • IMA Clinical Research - Albuquerque

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Neurological Associates of Albany

    Albany, New York 12208
    United States

    Site Not Available

  • Neurological Institute of New York

    New York, New York 10032
    United States

    Site Not Available

  • SUNY Upstate Medical University - Upstate University Hospital (SUNY Health Science Center)

    Syracuse, New York 13210-2342
    United States

    Site Not Available

  • AMC Research

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH)

    Lakewood, Ohio 44107
    United States

    Site Not Available

  • Summit Research Network

    Portland, Oregon 97210
    United States

    Site Not Available

  • Abington Neurological Associates

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Keystone Clinical Research

    Norristown, Pennsylvania 19462
    United States

    Site Not Available

  • Rhode Island Mood and Memory

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Neurology Clinic. P.C

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • The Alliance for Multispecialty Research LLC (AMR)

    Knoxville, Tennessee 37920-1511
    United States

    Site Not Available

  • The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)

    Knoxville, Tennessee 37920-1511
    United States

    Site Not Available

  • Senior Adult Specialty Research

    Austin, Texas 78757
    United States

    Site Not Available

  • Gadolin Research, LLC

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Kerwin Medical Center

    Dallas, Texas 75231
    United States

    Site Not Available

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