Phase
Condition
N/ATreatment
sabirnetug
ACU193
Placebo
Clinical Study ID
Ages 50-90 All Genders
Study Summary
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
National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mildcognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD
Screening score between 22 and 30 (inclusive) on the Mini-Mental StateExamination (MMSE)
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
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:
Any suicide attempt or preparatory acts/behavior on the C-SSRSBaseline/Screening in the last six months
Suicidal ideation in the last six months as defined by a positive response toQuestion 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening
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
Connect with a study center
Okanagan Clinical Trials
Kelowna, British Columbia
CanadaSite Not Available
Office of Alexandre Henri-Bhargava, MD
Victoria, British Columbia
CanadaSite Not Available
Parkwood Institute
London, Ontario
CanadaSite Not Available
Hippocampe d/b/a Ottawa Memory Clinic
Ottawa, Ontario
CanadaSite Not Available
The Kawartha Regional Memory Clinic (KRMC)
Peterborough, Ontario
CanadaSite Not Available
Baycrest - The Rotman Research Institute (RRI)
Toronto, Ontario
CanadaSite Not Available
Toronto Memory Program (TMP) (Neurology Research Inc.)
Toronto, Ontario
CanadaSite Not Available
University Health Network (UHN) - Toronto Western Hospital (TWH) - Krembil Neuroscience Centre (KNC) - Memory Clinic
Toronto, Ontario
CanadaSite Not Available
MoCA Research and Innovations
Greenfield Park, Quebec
CanadaSite Not Available
Amiens university hospital
Amiens,
FranceSite Not Available
Chu Pellegrin
Bordeaux,
FranceSite Not Available
Hopital Neurologique Pierre Wertheimer
Bron,
FranceSite Not Available
Hôpital de la Timone
Marseille Cedex 05,
FranceSite Not Available
Chu Montpellier
Montpellier,
FranceSite Not Available
Hopital Lariboisiere
Paris,
FranceSite Not Available
Institut de la Mémoire et de la Maladie d'Alzheimer -IM2A
Paris,
FranceSite Not Available
CHU de Rennes, CMRR
Rennes,
FranceSite Not Available
CHU de NANTES-Hôpital Nord Laennec
Saint-Herblain,
FranceSite Not Available
Hôpitaux Universitaires de Strasbourg
Strasbourg,
FranceSite Not Available
Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave
Toulouse,
FranceSite Not Available
Charité - Universitaetsmedizin Berlin
Berlin,
GermanySite Not Available
Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz,
GermanySite Not Available
University Hospital of Cologne
Cologne,
GermanySite Not Available
Saarland University Hospital
Homburg,
GermanySite Not Available
Zentralinstitut für seelische Gesundheit
Mannheim,
GermanySite Not Available
Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar
Munich,
GermanySite Not Available
Rostock University Medical Center
Rostock,
GermanySite Not Available
Praxisgemeinschaft Dr. Springub/Schwarz
Westerstede,
GermanySite Not Available
Fondazione Istituto G. Giglio di Cefalù
Cefalù,
ItalySite Not Available
Policlinico San Martino
Genova,
ItalySite Not Available
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano,
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza,
ItalySite Not Available
Neurology Clinic
Perugia,
ItalySite Not Available
IRCCS Neuromed
Pozzilli,
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma,
ItalySite Not Available
Sapienza Università di Roma - AOU Policlinico Umberto I
Roma,
ItalySite Not Available
SSD Alzheimer's disease and related dementias
Torino,
ItalySite Not Available
A.O. Piafondazione Card. G. Panico
Tricase,
ItalySite Not Available
Centrum Medyczne Neuromed
Bydgoszcz,
PolandSite Not Available
Krakowska Akademia Neurologii Sp. z o.o.
Krakow,
PolandSite Not Available
NZOZ Syntonia
Pruszcz Gdanski,
PolandSite Not Available
RCMed
Sochaczew,
PolandSite Not Available
Centrum Medyczne Senior
Sopot,
PolandSite Not Available
Centrum Medyczne NeuroProtect
Warsaw,
PolandSite Not Available
Hospital Universitari General de catalunya
Sant Cugat Del Vallès, Barcelona
SpainSite Not Available
Fundacion CITA alzheimer
San Sebastián, Gipuzkoa
SpainSite Not Available
Fundacion Neuropolis - Hospital Viamed Montecanal
Cuarte de Huerva, Zaragoza
SpainSite Not Available
Fundacio ACE
Barcelona,
SpainSite Not Available
Hospital Universitario Reina Sofia
Cordoba,
SpainSite Not Available
Cae Oroitu
Getxo,
SpainSite Not Available
Hospital Ruber
Madrid,
SpainSite Not Available
Policlínica Gipuzkoa
San Sebastian,
SpainSite Not Available
Hospital Victoria Eugenia
Sevilla,
SpainSite Not Available
Hospital Universitari i Politècnic La Fe
Valencia,
SpainSite Not Available
Re:Cognition Health - Plymouth
Plymouth, Devon
United KingdomSite Not Available
Panthera Biopartners - Enfield
Enfield Town, Greater London
United KingdomSite Not Available
Re:Cognition Health - London
London, Greater London
United KingdomSite Not Available
St. Pancras Clinical Research Ltd.
London, Greater London
United KingdomSite Not Available
Panthera Bio-Partners - Rochdale
Rochdale, Greater Manchester
United KingdomSite Not Available
Re:Cognition Health - Winchester
Winchester, Hampshire
United KingdomSite Not Available
Neuroclin Glasgow
Motherwell, Lanarkshire
United KingdomSite Not Available
Panthera Bio-Partners - Preston
Preston, Lancashire
United KingdomSite Not Available
Re:Cognition Health - Guildford
Guildford, Surrey
United KingdomSite Not Available
Re:Cognition Health - Birmingham
Birmingham, West Midlands
United KingdomSite Not Available
Panthera Biopartners - Sheffield
Sheffield, Yorkshire
United KingdomSite Not Available
Re:Cognition Health - Bristol
Bristol,
United KingdomSite Not Available
Banner Alzheimer's Institute- Clinical Trials Department
Phoenix, Arizona 85006
United StatesSite Not Available
IMA Clinical Research - Phoenix
Phoenix, Arizona 85012
United StatesSite Not Available
The Neurology Center of Southern California - Carlsbad
Carlsbad, California 92011-4219
United StatesSite Not Available
Neurology Center of North Orange County
Fullerton, California 92835
United StatesSite Not Available
Irvine Medical Research
Irvine, California 92614
United StatesSite Not Available
Healthy Brain Research
Long Beach, California 90804
United StatesSite Not Available
Sharp Mesa Vista Hospital
San Diego, California 92123
United StatesSite Not Available
Syrentis Clinical Research
Santa Ana, California 92705
United StatesSite Not Available
CenExel - California Neuroscience Research Medical Group, Inc (CNR)
Sherman Oaks, California 91403-2131
United StatesSite Not Available
Alpine Clinical Research Center
Boulder, Colorado 80301-1880
United StatesSite Not Available
The Mile High Research Center
Denver, Colorado 80218
United StatesSite Not Available
Yale School of Medicine - Alzheimer's Disease Research Unit (ADRU)
New Haven, Connecticut 06510-3330
United StatesSite Not Available
Research Center for Clinical Studies, LLC
Norwalk, Connecticut 06851-4903
United StatesSite Not Available
Re:Cognition Health - Fairfax
Washington, District of Columbia 22031
United StatesSite Not Available
JEM Research Institute
Atlantis, Florida 33462
United StatesSite Not Available
Bradenton Research Center
Bradenton, Florida 34205
United StatesSite Not Available
Gil Fernandez-Yera, MD, PA
Coral Gables, Florida 33135
United StatesSite Not Available
Brain Matters Research
Delray Beach, Florida 33445
United StatesSite Not Available
Coral Clinical Research
Homestead, Florida 33032
United StatesSite Not Available
K2 Medical Research - Villages
Lady Lake, Florida 32159
United StatesSite Not Available
Finlay Medical Research
Miami, Florida 33126
United StatesSite Not Available
Verus Clinical Research
Miami, Florida 33125
United StatesSite Not Available
Collier Neurologic Specialists (CNS), L.L.C.
Naples, Florida 34105-8522
United StatesSite Not Available
Ocala Health - Family Care Specialists - Ocala I
Ocala, Florida 34470
United StatesSite Not Available
Progressive Medical Research
Port Orange, Florida 32127
United StatesSite Not Available
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida 34997
United StatesSite Not Available
K2 Medical Research - Tampa
Tampa, Florida 33607
United StatesSite Not Available
Charter Research - Lady Lake
The Villages, Florida 32162
United StatesSite Not Available
Alzheimers Research and Treatment Center - Wellington
Wellington, Florida 33414
United StatesSite Not Available
Charter Research - Winter Park
Winter Park, Florida 32792
United StatesSite Not Available
Conquest Research
Winter Park, Florida 32789
United StatesSite Not Available
Columbus Memory Center
Columbus, Georgia 31909
United StatesSite Not Available
Accel Research- Neurostudies
Decatur, Georgia 30030
United StatesSite Not Available
CenExel - iResearch Atlanta
Decatur, Georgia 30030
United StatesSite Not Available
CenExel - iResearch Savannah
Savannah, Georgia 31405
United StatesSite Not Available
Office of Jeffrey S. Ross, MD
Northbrook, Illinois 60640
United StatesSite Not Available
KU Wichita Center for Clinical Research
Wichita, Kansas 67214
United StatesSite Not Available
ActivMed Practices and Research
Methuen, Massachusetts 03801
United StatesSite Not Available
Boston Center for Memory
Newton, Massachusetts 02459
United StatesSite Not Available
Donald S. Marks, MD. P.C.
Plymouth, Massachusetts 02360
United StatesSite Not Available
Hattiesburg Clinic - Memory Center
Hattiesburg, Mississippi 39401-7246
United StatesSite Not Available
Las Vegas Medical Research Center
Las Vegas, Nevada 89113-2215
United StatesSite Not Available
ActivMed Practices and Research
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Princeton Psychiatric Center
Princeton, New Jersey 08540-2859
United StatesSite Not Available
The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
United StatesSite Not Available
CenExel - Advanced Memory Research Institute of NJ
Toms River, New Jersey 08755
United StatesSite Not Available
IMA Clinical Research - Albuquerque
Albuquerque, New Mexico 87109
United StatesSite Not Available
Neurological Associates of Albany
Albany, New York 12208
United StatesSite Not Available
Neurological Institute of New York
New York, New York 10032
United StatesSite Not Available
SUNY Upstate Medical University - Upstate University Hospital (SUNY Health Science Center)
Syracuse, New York 13210-2342
United StatesSite Not Available
AMC Research
Matthews, North Carolina 28105
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH)
Lakewood, Ohio 44107
United StatesSite Not Available
Summit Research Network
Portland, Oregon 97210
United StatesSite Not Available
Abington Neurological Associates
Abington, Pennsylvania 19001
United StatesSite Not Available
Keystone Clinical Research
Norristown, Pennsylvania 19462
United StatesSite Not Available
Rhode Island Mood and Memory
East Providence, Rhode Island 02914
United StatesSite Not Available
Neurology Clinic. P.C
Cordova, Tennessee 38018
United StatesSite Not Available
The Alliance for Multispecialty Research LLC (AMR)
Knoxville, Tennessee 37920-1511
United StatesSite Not Available
The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)
Knoxville, Tennessee 37920-1511
United StatesSite Not Available
Senior Adult Specialty Research
Austin, Texas 78757
United StatesSite Not Available
Gadolin Research, LLC
Beaumont, Texas 77702
United StatesSite Not Available
Kerwin Medical Center
Dallas, Texas 75231
United StatesSite Not Available
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