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New drug sabirnetug aims to slow Alzheimer's decline

NCT ID NCT06335173

Disease control Sponsor: Acumen Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 2 trial tests whether sabirnetug, given as an IV infusion every four weeks, can slow cognitive and functional decline in people with early Alzheimer's disease. About 542 participants will receive either sabirnetug or a placebo. The main outcome is change in a combined score of memory and daily living skills over time.

What this could mean

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

Active substance
sabirnetug (given as an intravenous infusion every 4 weeks)
What this could lead to
If successful, sabirnetug could become a new treatment option to slow memory loss and functional decline in early Alzheimer's disease.
What could go wrong
This is a Phase 2 trial, so it is still early. The drug may not show enough benefit over placebo, and there could be side effects from the infusions.

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

542 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Oct 2026

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 90 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.

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 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: * Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI * 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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction Memory Disorders

As listed by the trial registrant

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

Alzheimer disease

Contacts and locations

Locations

  • AMC Research

    Matthews, North Carolina, 28105, United States

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001, United States

  • ActivMed Practices and Research

    Portsmouth, New Hampshire, 03801, United States

  • Alzheimer's Research and Treatment Center - Stuart

    Stuart, Florida, 34997, United States

  • Alzheimers Research and Treatment Center - Wellington

    Wellington, Florida, 33414, United States

  • Aqualane Clinical Research

    Naples, Florida, 34105-8522, United States

  • Boston Center for Memory

    Newton, Massachusetts, 02459, United States

  • Bradenton Research Center

    Bradenton, Florida, 34205, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • Cae Oroitu

    Getxo, Spain

  • CenExel - Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755, United States

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

    Sherman Oaks, California, 91403-2131, United States

  • CenExel - iResearch Atlanta

    Decatur, Georgia, 30030, United States

  • Charité - Universitaetsmedizin Berlin

    Berlin, Germany

  • Charter Research - Lady Lake

    The Villages, Florida, 32162, United States

  • Charter Research - Winter Park

    Winter Park, Florida, 32792, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbus Memory Center

    Columbus, Georgia, 31909, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Coral Clinical Research

    Homestead, Florida, 33032, United States

  • Finlay Medical Research

    Miami, Florida, 33126, United States

  • Fundacio ACE

    Barcelona, Spain

  • Fundacion Neuropolis - Hospital Viamed Montecanal

    Cuarte de Huerva, Zaragoza, Spain

  • Gadolin Research, LLC

    Beaumont, Texas, 77702, United States

  • Gil Fernandez-Yera, MD, PA

    Coral Gables, Florida, 33135, United States

  • Hattiesburg Clinic - Memory Center

    Hattiesburg, Mississippi, 39401-7246, United States

  • Healthy Brain Research

    Long Beach, California, 90804, United States

  • Hippocampe d/b/a Ottawa Memory Clinic

    Ottawa, Ontario, Canada

  • Hospital Ruber

    Madrid, Spain

  • Hospital Universitari General de catalunya

    Sant Cugat del Vallès, Barcelona, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, Spain

  • Hospital Victoria Eugenia

    Seville, Spain

  • Irvine Medical Research

    Irvine, California, 92614, United States

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • K2 Medical Research - Tampa

    Tampa, Florida, 33607, United States

  • K2 Medical Research - Villages

    Lady Lake, Florida, 32159, United States

  • Kerwin Medical Center

    Dallas, Texas, 75231, United States

  • Keystone Clinical Research

    Norristown, Pennsylvania, 19462, United States

  • MoCA Research and Innovations

    Greenfield Park, Quebec, Canada

  • Neuroclin Glasgow

    Motherwell, Lanarkshire, United Kingdom

  • Neurological Associates of Albany

    Albany, New York, 12208, United States

  • Neurology Center of North Orange County

    Fullerton, California, 92835, United States

  • Neurology Clinic. P.C

    Cordova, Tennessee, 38018, United States

  • Ocala Health - Family Care Specialists - Ocala I

    Ocala, Florida, 34470, United States

  • Office of Jeffrey S. Ross, MD

    Northbrook, Illinois, 60640, United States

  • Okanagan Clinical Trials

    Kelowna, British Columbia, Canada

  • Panthera Bio-Partners - Preston

    Preston, Lancashire, United Kingdom

  • Panthera Biopartners - Sheffield

    Sheffield, Yorkshire, United Kingdom

  • Policlínica Gipuzkoa

    Donostia / San Sebastian, Spain

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Re:Cognition Health - Bristol

    Bristol, United Kingdom

  • Re:Cognition Health - Fairfax

    Washington D.C., District of Columbia, 22031, United States

  • Re:Cognition Health - Guildford

    Guildford, Surrey, United Kingdom

  • Re:Cognition Health - London

    London, Greater London, United Kingdom

  • Re:Cognition Health - Winchester

    Winchester, Hampshire, United Kingdom

  • Research Center for Clinical Studies, LLC

    Norwalk, Connecticut, 06851-4903, United States

  • Rhode Island Mood and Memory

    East Providence, Rhode Island, 02914, United States

  • Senior Adult Specialty Research

    Austin, Texas, 78757, United States

  • St. Pancras Clinical Research Ltd.

    London, Greater London, United Kingdom

  • Summit Research Network

    Portland, Oregon, 97210, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

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

    Munich, Germany

  • The Alliance for Multispecialty Research LLC (AMR)

    Knoxville, Tennessee, 37920-1511, United States

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081, United States

  • The Neurology Center of Southern California - Carlsbad

    Carlsbad, California, 92011-4219, United States

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

    Toronto, Ontario, Canada

  • University Hospital of Cologne

    Cologne, Germany

  • Zentralinstitut für seelische Gesundheit

    Mannheim, Germany

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