🏛️ Verified NIH Record • Updated 2025-10-23

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD) (NCT06335173)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Acumen Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (13 items).

Location: The Neurology Center of Southern California - Carlsbad — Carlsbad, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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:
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (68 Sites)

  • The Neurology Center of Southern California - Carlsbad — Carlsbad, California
  • Neurology Center of North Orange County — Fullerton, California
  • Irvine Medical Research — Irvine, California
  • Healthy Brain Research — Long Beach, California
  • Syrentis Clinical Research — Santa Ana, California
  • CenExel - California Neuroscience Research Medical Group, Inc (CNR) — Sherman Oaks, California
  • Research Center for Clinical Studies, LLC — Norwalk, Connecticut
  • Re:Cognition Health - Fairfax — Washington D.C., District of Columbia
  • JEM Research Institute — Atlantis, Florida
  • Bradenton Research Center — Bradenton, Florida
  • Gil Fernandez-Yera, MD, PA — Coral Gables, Florida
  • Brain Matters Research — Delray Beach, Florida
  • Coral Clinical Research — Homestead, Florida
  • K2 Medical Research - Villages — Lady Lake, Florida
  • Finlay Medical Research — Miami, Florida
  • Aqualane Clinical Research — Naples, Florida
  • Ocala Health - Family Care Specialists - Ocala I — Ocala, Florida
  • Progressive Medical Research — Port Orange, Florida
  • Alzheimer's Research and Treatment Center - Stuart — Stuart, Florida
  • K2 Medical Research - Tampa — Tampa, Florida
  • Charter Research - Lady Lake — The Villages, Florida
  • Alzheimers Research and Treatment Center - Wellington — Wellington, Florida
  • Conquest Research — Winter Park, Florida
  • Charter Research - Winter Park — Winter Park, Florida
  • Columbus Memory Center — Columbus, Georgia

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗