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Yearly Alzheimer's shot could keep symptoms at bay

NCT ID NCT07602582

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tests whether people with Alzheimer's who already took the drug donanemab benefit from getting it just once a year. About 550 volunteers who finished a previous donanemab study will receive either the drug or a placebo for up to 2.5 years. Researchers will track changes in memory, daily function, and brain plaque levels.

What this could mean

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

Active substance
donanemab
What this could lead to
If it works, this could show that annual infusions of donanemab help keep Alzheimer's symptoms from getting worse over time.
What could go wrong
This is an extension study, so participants already responded to donanemab. It's unclear if annual dosing alone is enough, and the trial is still recruiting.

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

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2029

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

55 years and older

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: * Have completed study AACM Addendum 7. * Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. * Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study. * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. * Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution. * Contraindication to florbetapir F 18 PET. * Have had history of amyloid-targeting therapy treatment outside donanemab trials. * Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia Plaque, Amyloid

As listed by the trial registrant

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

Alzheimer disease Dementia Plaque, amyloid

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    59 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adult Medicine of Lake County, Inc.

    RECRUITING

    Mt. Dora, Florida, 32757, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    Riverside, California, 92503, United States

  • Artemis Institute for Clinical Research

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Banner Alzheimer's Institute

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85006, United States

  • Boston Center for Memory

    RECRUITING

    Newton, Massachusetts, 02459, United States

  • Bradenton Research Center, Inc.

    RECRUITING

    Bradenton, Florida, 34205, United States

  • Care Access - Huntington Beach

    RECRUITING

    Huntington Beach, California, 92648, United States

  • Care Access - Lake Charles (Bayou Pines)

    RECRUITING

    Lake Charles, Louisiana, 70601, United States

  • Care Access - Lima

    RECRUITING

    Lima, Ohio, 45805, United States

  • Care Access - South Indianapolis

    RECRUITING

    Indianapolis, Indiana, 46254, United States

  • Care Access - Tampa

    RECRUITING

    Tampa, Florida, 33625, United States

  • Center for Advanced Research & Education

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Charter Research - Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Charter Research - The Villages

    RECRUITING

    The Villages, Florida, 32162, United States

  • Citizens Memorial Hospital District

    RECRUITING

    Bolivar, Missouri, 65613, United States

  • Clinical Trials Research

    RECRUITING

    Sacramento, California, 95821, United States

  • Conquest Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Consano Clinical Research, LLC

    NOT_YET_RECRUITING

    Shavano Park, Texas, 78231, United States

  • Covenant Medical Center

    NOT_YET_RECRUITING

    Waterloo, Iowa, 50702, United States

  • Emerald Coast Neurology - Airport Boulevard

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Finlay Medical Research

    RECRUITING

    Greenacres City, Florida, 33467, United States

  • Finlay Medical Research

    RECRUITING

    Miami, Florida, 33126, United States

  • Gadolin Research

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Great Lakes Clinical Trials - Andersonville

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Headlands Research Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Healthy Brain Clinic

    RECRUITING

    Long Beach, California, 90804, United States

  • Indago Research & Health Center, Inc

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Infectious Disease Doctors Medical Group, APC

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Irvine Clinical Research

    RECRUITING

    Irvine, California, 92614, United States

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Josephson Wallack Munshower Neurology, PC

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • K2 Medical Research - Tampa

    NOT_YET_RECRUITING

    Tampa, Florida, 33634, United States

  • K2 Medical Research ORLANDO

    RECRUITING

    Maitland, Florida, 32751, United States

  • MedVadis Research Corporation

    NOT_YET_RECRUITING

    Waltham, Massachusetts, 02451, United States

  • Merritt Island Medical Research, LLC

    RECRUITING

    Merritt Island, Florida, 32952, United States

  • Monroe Biomedical Research

    NOT_YET_RECRUITING

    Monroe, North Carolina, 28112, United States

  • NDx Clinical Research, Inc.

    NOT_YET_RECRUITING

    Dayton, Ohio, 45459, United States

  • National Center for Geriatrics and Gerontology

    NOT_YET_RECRUITING

    Ōbu, 474-8511, Japan

  • North Georgia Clinical Research

    RECRUITING

    Woodstock, Georgia, 30189, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Northwest Clinical Trials

    RECRUITING

    Boise, Idaho, 83704, United States

  • P-One Clinic

    NOT_YET_RECRUITING

    Hachiōji, 192-0071, Japan

  • Progressive Medical Research

    RECRUITING

    Port Orange, Florida, 32127, United States

  • Providence Medical Foundation

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Revival Research Institute, LLC

    NOT_YET_RECRUITING

    Southfield, Michigan, 48075, United States

  • SCB Research Center

    NOT_YET_RECRUITING

    Bayamón, 00961, Puerto Rico

  • Samoncho Clinic

    NOT_YET_RECRUITING

    Shinjuku, 160-0017, Japan

  • Senior Adults Specialty Research

    NOT_YET_RECRUITING

    Austin, Texas, 78757, United States

  • Suncoast Clinical Research, Inc.

    RECRUITING

    New Port Richey, Florida, 34652, United States

  • Syrentis Clinical Research

    RECRUITING

    Santa Ana, California, 92705, United States

  • The Cognitive and Research Center of New Jersey

    RECRUITING

    Springfield, New Jersey, 07081, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    NOT_YET_RECRUITING

    tabashi City, 173-0015, Japan

  • Tokyo-Eki Center-building Clinic

    NOT_YET_RECRUITING

    Chūōku, 103-0027, Japan

  • Universal Research Group

    RECRUITING

    Tacoma, Washington, 98405, United States

  • VIN - Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • VIN-Andrew Lerman

    RECRUITING

    Miami, Florida, 33133, United States

  • Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Yotsuya Internal Medicine Clinic

    NOT_YET_RECRUITING

    Shinjyuku, 160-0017, Japan

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