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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID: NCT06335173
Run by: Acumen Pharmaceuticals
People needed: 542
Starts: 2024-02-29
Expected to finish: 2026-10-01
Last updated by the study team: 2025-10-27

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD
Screening score between 22 and 30 (inclusive) on the Mini-Mental State Examination (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 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

You may not qualify if…

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:
Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months
Suicidal ideation in the last six months as defined by a positive response to Question 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

Where it is running

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
The Neurology Center of Southern California - Carlsbad — Carlsbad, California, United States

Full record on ClinicalTrials.gov

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