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New dosing strategy aims to make Alzheimer's drug safer and more effective

NCT ID NCT05738486

Disease control Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests different dosing schedules of the drug donanemab in about 1,175 people with early symptomatic Alzheimer's disease. The goal is to find a regimen that lowers brain amyloid plaques while reducing the risk of a side effect called ARIA-E (brain swelling or small bleeds). Participants will receive donanemab infusions and be monitored for up to 91 weeks. The study also looks at patient traits that might predict who is more likely to develop ARIA.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,175 people

The number who actually took part.

Started

Feb 2023

Expected to finish

May 2027

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

60 to 85 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: * Gradual and progressive change in memory function reported by the participant or informant for ≥6 months. * A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening. * Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology. Exclusion Criteria: * Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures. * Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study. * A life expectancy of \<24 months. * Contraindication to MRI or PET scans * Have had prior treatment with a passive anti-amyloid immunotherapy. * Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1. Exceptions: * non-metastatic basal- or squamous-cell skin cancer * Stage 0 non-invasive carcinoma of the cervix * Stage 0 non-invasive prostate cancer, or * other cancers with low risk of recurrence or spread

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Conditions

The condition(s) this trial relates to.

Alzheimer disease brain disorder central nervous system disorder cognitive disorder dementia mental disorder nervous system disorder neurodegenerative disease psychiatric disorder

As listed by the trial registrant

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

Alzheimer's disease Brain diseases Central nervous system diseases Dementia Mental disorders Nervous system diseases Neurocognitive disorders Neurodegenerative diseases

Contacts and locations

Locations

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34997, United States

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403, United States

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501, United States

  • Charter Research - Lady Lake

    The Villages, Florida, 32162, United States

  • Charter Research - Winter Park

    Orlando, Florida, 32803, United States

  • ClinCloud - Maitland

    Maitland, Florida, 32751, United States

  • ClinCloud - Viera

    Melbourne, Florida, 32940, United States

  • Columbus Memory Center, LLC

    Columbus, Georgia, 31909, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434, United States

  • Finlay Medical Research

    Greenacres City, Florida, 33467, United States

  • Gadolin Research

    Beaumont, Texas, 77702, United States

  • Healthy Brain Clinic

    Long Beach, California, 90804, United States

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024, United States

  • Irvine Clinical Research

    Irvine, California, 92614, United States

  • JEM Research Institute

    Atlantis, Florida, 33462, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • K2 Medical Research

    Clermont, Florida, 34711, United States

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • K2 Medical Research - Tampa

    Tampa, Florida, 33607, United States

  • K2 Summit Research

    The Villages, Florida, 32159, United States

  • Kerwin Medical Center

    Dallas, Texas, 75231, United States

  • MD First Research - Chandler

    Chandler, Arizona, 85286, United States

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451, United States

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Palm Beach Neurology

    West Palm Beach, Florida, 33407, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Re:Cognition Health

    Fairfax, Virginia, 22031, United States

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT, United Kingdom

  • Re:Cognition Health - Bristol

    Bristol, Bristol, City of, BS32 4SY, United Kingdom

  • Re:Cognition Health - London

    London, London, City of, W1G 9JF, United Kingdom

  • Re:Cognition Health - Plymouth

    Plymouth, PL6 8BT, United Kingdom

  • Re:Cognition Health - Winchester

    Winchester, Hampshire, SO21 1HU, United Kingdom

  • Re:Cognition Health Guildford

    Guildford, Reading, GU2 7YD, United Kingdom

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652, United States

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77054, United States

  • Universal Research Group

    Tacoma, Washington, 98405, United States

  • VIN-Julie Schwartzbard

    Aventura, Florida, 33180, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.