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ACTIVE NOT RECRUITING

NCT06335173

PHASE2

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

Sponsor: Acumen Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Intravenous Sabirnetug in Early Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

542

Start Date

2024-02-29

Completion Date

2026-10

Last Updated

2025-10-27

Healthy Volunteers

Conditions

Alzheimer Disease

Interventions

DRUG

sabirnetug

Intravenous sabirnetug

DRUG

Placebo

Intravenous Placebo

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

Locations (68)

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