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Alzheimer DiseasePhase 3NCT07602582

A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

A Phase 3 study testing Donanemab in people with Alzheimer Disease and Dementia, run by Eli Lilly and Company at 62 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer Disease, Dementia, Plaque, Amyloid
What is being tested?
Donanemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
62 sitesin 3 countries
Study dates
22 May 2026to Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

62 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

62 sites in 3 countries

United States55 sites, 55 recruiting

  • Senior Adults Specialty Research

    Austin, Texas, 78757

    512-407-8628

    John Bertelson

    Recruiting

  • VIN - Aventura

    Aventura, Florida, 33180

    305-933-5993

    Jonathan Cross

    Recruiting

  • Gadolin Research

    Beaumont, Texas, 77702

    409-331-6040

    Joseph Oommen

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    Jeena Vaid

    Recruiting

  • Northwest Clinical Trials

    Boise, Idaho, 83704

    208-685-0600

    Brock McConnehey

    Recruiting

  • Citizens Memorial Hospital District

    Bolivar, Missouri, 65613

    417-328-7781

    Curtis Schreiber

    Recruiting

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

    941-708-0005

    Eric Folkens

    Recruiting

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

    773-275-3500

    Jeffrey Ross

    Recruiting

  • K2 Medical Research WINTER GARDEN

    Clermont, Florida, 34711

    321-234-0199

    Christopher Galloway

    Recruiting

  • NDx Clinical Research, Inc.

    Dayton, Ohio, 45459

    937-224-8200

    Joel Vandersluis

    Recruiting

  • K2 Medical Research - Daytona Beach

    Daytona Beach, Florida, 32114

    Joshua Eisenhut

    Recruiting

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

    770-534-5154

    Angela Ritter

    Recruiting

  • Finlay Medical Research

    Greenacres City, Florida, 33467

    561-766-2181

    Jorge Calle Medina

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77054

    713-486-0536

    David Hunter

    Recruiting

  • Care Access - Huntington Beach

    Huntington Beach, California, 92648

    714-378-2440

    Christine Thai

    Recruiting

  • Care Access - South Indianapolis

    Indianapolis, Indiana, 46254

    877-791-0656

    Gigi Lefebvre

    Recruiting

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, 46256

    317-537-6099

    Kristi George

    Recruiting

  • Irvine Clinical Research

    Irvine, California, 92614

    949-753-1663

    Elly Lee

    Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

    904-730-0101

    Steven Toenjes

    Recruiting

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida, 32159

    352-500-5252

    Craig Curtis

    Recruiting

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, Louisiana, 70601

    337-602-6642

    Jason Morris

    Recruiting

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

    702-750-000

    Bharat Mocherla

    Recruiting

  • Care Access - Lima

    Lima, Ohio, 45805

    877-791-0656

    Gigi Lefebvre

    Recruiting

  • Healthy Brain Clinic

    Long Beach, California, 90804

    562-606-5999

    Dung Trinh

    Recruiting

  • K2 Medical Research ORLANDO

    Maitland, Florida, 32751

    407-500-5252

    Brandon Lenox

    Recruiting

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

    David Kirk

    Recruiting

  • Finlay Medical Research

    Miami, Florida, 33126

    Lilia Rodriguez Ables

    Recruiting

  • VIN-Andrew Lerman

    Miami, Florida, 33133

    786-655-8010

    Andrew Lerman

    Recruiting

  • Indago Research & Health Center, Inc

    Miami Lakes, Florida, 33016

    305-825-6588

    Jose Cardona

    Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

    704-283-7359

    Awawu Igbinadolor

    Recruiting

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757

    352-383-8222

    Shirley Nagel

    Recruiting

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

    727-849-4131

    Cathy Barnes

    Recruiting

  • Boston Center for Memory

    Newton, Massachusetts, 02459

    617-699-6927

    Paul Solomon

    Recruiting

  • Charter Research - Orlando

    Orlando, Florida, 32803

    407-337-3000

    Edgardo Rivera-Rivera

    Recruiting

  • Headlands Research Orlando

    Orlando, Florida, 32806

    407-705-3471

    Uzma Khan

    Recruiting

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, Florida, 32504

    850-438-1136

    David Bear

    Recruiting

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

    602-839-6900

    Po-Heng Tsai

    Recruiting

  • Progressive Medical Research

    Port Orange, Florida, 32127

    386-304-7070

    Alexander White

    Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

    951-374-1190

    Jack Vu

    Recruiting

  • Headlands Research- Sacramento

    Sacramento, California, 95821

    916-434-8230

    Jeffrey Wayne

    Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

    858-278-3647

    Eric Chavez

    Recruiting

  • Syrentis Clinical Research

    Santa Ana, California, 92705

    714-542-3008

    John Duffy

    Recruiting

  • Providence Medical Foundation

    Santa Rosa, California, 95403

    707-521-3830

    Allan Bernstein

    Recruiting

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

    210-545-4900

    Michelle Welch

    Recruiting

  • Revival Research Institute, LLC

    Southfield, Michigan, 48075

    586-276-7453

    Abdulhassan Saad

    Recruiting

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

    Raminder Parihar

    Recruiting

  • Universal Research Group

    Tacoma, Washington, 98405

    253-882-1070

    Sabrina Benjamin

    Recruiting

  • Care Access - Tampa

    Tampa, Florida, 33625

    877-791-0656

    Brad Lipson

    Recruiting

  • K2 Medical Research - Tampa

    Tampa, Florida, 33634

    813-800-5252

    Kelley Wilson

    Recruiting

  • Charter Research - The Villages

    The Villages, Florida, 32162

    352-441-2000

    Jeffrey Norton

    Recruiting

  • Infectious Disease Doctors Medical Group, APC

    Walnut Creek, California, 94598

    925-947-2334

    Bhavna Malik

    Recruiting

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

    617-744-1310

    David DiBenedetto

    Recruiting

  • Covenant Medical Center

    Waterloo, Iowa, 50702

    319-272-2112

    NICHOLAS GOETSCH

    Recruiting

  • Conquest Research

    Winter Park, Florida, 32789

    407-916-0060

    Rekha Gandhi

    Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

    678-494-5735

    Bram Wieskopf

    Recruiting

Other trials in United States

Japan6 sites, 6 recruiting

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

    81120023812

    Arihiro Kiyosue

    Recruiting

  • P-One Clinic

    Hachiōji, 192-0071

    81120023812

    Kenichi Furihata

    Recruiting

  • National Center for Geriatrics and Gerontology

    Ōbu, 474-8511

    81120023812

    MASASHI TSUJIMOTO

    Not yet recruiting

  • Samoncho Clinic

    Shinjuku, 160-0017

    81120023812

    Takahiro Yokoyama

    Not yet recruiting

  • Yotsuya Internal Medicine Clinic

    Shinjyuku, 160-0017

    81120023812

    takahiro yokoyama

    Recruiting

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    tabashi City, 173-0015

    81120023812

    Atsushi Iwata

    Recruiting

Other trials in Japan

Puerto Rico1 site, 1 recruiting

  • SCB Research Center

    Bayamón, 00961

    (787) 798-4592

    William Julio

    Recruiting

Other trials in Puerto Rico

About this study

Official title: An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM

The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.

Being tested
Donanemab, Placebo
Keywords
Donanemab
Medical subject headings
Alzheimer Disease, Dementia, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonanemabDrug

    Administered IV

  • PlaceboDrug

    Administered IV

Study groups in NCT07602582
Study groupRoleWhat they receive
DonanemabExperimentalDonanemab administered intravenously (IV)
Receives: Drug: Donanemab
PlaceboPlacebo comparatorPlacebo IV
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)

    Measured: Baseline through Week 130

Secondary outcomes (4)

  1. Change from Baseline as Measured by Cognitive Function Index (CFI)

    Measured: Baseline through Week 130

  2. Change from Baseline in Brain Amyloid Plaque Levels as Measured by Florbetapir F 18 Positron Emission Tomography (PET) Scan.

    Measured: Baseline through Week 130

  3. Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)

    Measured: Baseline through Week 130

  4. Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab

    Measured: Baseline, Week 52, Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start22 May 2026
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07602582
Sponsor's protocol ID
27890
Other IDs
I5T-MC-AACY
Status last verified
Oct 2026
First submitted
15 May 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Donanemab in people with Alzheimer Disease and Dementia, run by Eli Lilly and Company at 62 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB) (time frame: Baseline through Week 130). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07602582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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