A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)
NCT ID: NCT06335173
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
542 participants
INTERVENTIONAL
2024-02-29
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Double-blind Treatment (DBT) Period: sabirnetug 35 mg/kg
Participants will receive sabirnetug, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period.
sabirnetug
Intravenous sabirnetug
DBT Period: sabirnetug 50 mg/kg
Participants will receive sabirnetug, 35 mg/kg, for the first two doses, followed by sabirnetug, 50 mg/kg, Q4W as an IV infusion during the DBT period.
sabirnetug
Intravenous sabirnetug
DBT Period: Placebo
Participants will receive sabirnetug matching placebo, Q4W as an IV infusion during the DBT period.
Placebo
Intravenous Placebo
Open-Label Extension (OLE) Period: sabirnetug 35 mg/kg
Participants will receive sabirnetug, 35 mg/kg, Q4W as an IV infusion during the OLE period.
sabirnetug
Intravenous sabirnetug
Interventions
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sabirnetug
Intravenous sabirnetug
Placebo
Intravenous Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD
2. Screening score between 22 and 30 (inclusive) on the Mini-Mental State Examination (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 and every 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 perform all the roles as specified in the study partner Informed Consent Form (ICF)
* Female participants must be surgically sterile or be at least one-year post-menopausal. Male participants with a female partner of child-bearing potential must use adequate contraception
Exclusion Criteria
* MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis
* History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease
* Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant's safety or ability to complete the study
* Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)
* Geriatric Depression Scale-Short Form (GDS-SF) score \>10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, 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-SSRS Baseline/Screening in the last six months
2. Suicidal ideation in the last six months as defined by a positive response to Question 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
50 Years
90 Years
ALL
No
Sponsors
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Acumen Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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The Neurology Center of Southern California - Carlsbad
Carlsbad, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Irvine Medical Research
Irvine, California, United States
Healthy Brain Research
Long Beach, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
CenExel - California Neuroscience Research Medical Group, Inc (CNR)
Sherman Oaks, California, United States
Research Center for Clinical Studies, LLC
Norwalk, Connecticut, United States
Re:Cognition Health - Fairfax
Washington D.C., District of Columbia, United States
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Gil Fernandez-Yera, MD, PA
Coral Gables, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Coral Clinical Research
Homestead, Florida, United States
K2 Medical Research - Villages
Lady Lake, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Ocala Health - Family Care Specialists - Ocala I
Ocala, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Alzheimer's Research and Treatment Center - Stuart
Stuart, Florida, United States
K2 Medical Research - Tampa
Tampa, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Alzheimers Research and Treatment Center - Wellington
Wellington, Florida, United States
Conquest Research
Winter Park, Florida, United States
Charter Research - Winter Park
Winter Park, Florida, United States
Columbus Memory Center
Columbus, Georgia, United States
CenExel - iResearch Atlanta
Decatur, Georgia, United States
Office of Jeffrey S. Ross, MD
Northbrook, Illinois, United States
Boston Center for Memory
Newton, Massachusetts, United States
Hattiesburg Clinic - Memory Center
Hattiesburg, Mississippi, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
CenExel - Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States
Neurological Associates of Albany
Albany, New York, United States
AMC Research
Matthews, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Summit Research Network
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Keystone Clinical Research
Norristown, Pennsylvania, United States
Rhode Island Mood and Memory
East Providence, Rhode Island, United States
Neurology Clinic. P.C
Cordova, Tennessee, United States
The Alliance for Multispecialty Research LLC (AMR)
Knoxville, Tennessee, United States
Senior Adult Specialty Research
Austin, Texas, United States
Gadolin Research, LLC
Beaumont, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Hippocampe d/b/a Ottawa Memory Clinic
Ottawa, Ontario, Canada
Toronto Memory Program (TMP) (Neurology Research Inc.)
Toronto, Ontario, Canada
MoCA Research and Innovations
Greenfield Park, Quebec, Canada
Charité - Universitaetsmedizin Berlin
Berlin, , Germany
University Hospital of Cologne
Cologne, , Germany
Zentralinstitut für seelische Gesundheit
Mannheim, , Germany
Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar
Munich, , Germany
Hospital Universitari General de catalunya
Sant Cugat del Vallès, Barcelona, Spain
Fundacion Neuropolis - Hospital Viamed Montecanal
Cuarte de Huerva, Zaragoza, Spain
Fundacio ACE
Barcelona, , Spain
Policlínica Gipuzkoa
Donostia / San Sebastian, , Spain
Cae Oroitu
Getxo, , Spain
Hospital Ruber
Madrid, , Spain
Hospital Victoria Eugenia
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Re:Cognition Health - London
London, Greater London, United Kingdom
St. Pancras Clinical Research Ltd.
London, Greater London, United Kingdom
Re:Cognition Health - Winchester
Winchester, Hampshire, United Kingdom
Neuroclin Glasgow
Motherwell, Lanarkshire, United Kingdom
Panthera Bio-Partners - Preston
Preston, Lancashire, United Kingdom
Re:Cognition Health - Guildford
Guildford, Surrey, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, Yorkshire, United Kingdom
Re:Cognition Health - Bristol
Bristol, , United Kingdom
Countries
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References
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Siemers E, Feaster T, Sethuraman G, Sundell K, Skljarevski V, Cline EN, Zhang H, Jerecic J, Honig LS, Salloway S, Sperling R, Trame MN, Dodds MG, Johnson K. INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease. J Prev Alzheimers Dis. 2025 Jan;12(1):100005. doi: 10.1016/j.tjpad.2024.100005. Epub 2025 Jan 1.
Other Identifiers
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2023-509807-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACU193-201
Identifier Type: -
Identifier Source: org_study_id
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