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Could a new drug slow lewy body dementia? phase 2 trial begins

NCT ID NCT07589595

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 11 times

Summary

This phase 2 trial tests whether donanemab, an antibody given by IV, can slow worsening of thinking and daily function in people with early cognitive decline and Lewy body dementia. The study enrolls 350 participants who also have signs of two brain proteins (amyloid and alpha-synuclein). Each person will be followed for 1.5 years, comparing donanemab to a placebo.

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 successful, this could point toward a treatment that slows cognitive and functional decline in people with early Lewy body dementia.
What could go wrong
This is a phase 2 trial with only 350 participants, so results may not confirm effectiveness. Donanemab also carries risks like brain swelling or bleeding, and the trial requires confirmation of specific brain proteins, which may limit who can benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 350 people

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

Started

May 2026

Expected to finish

Aug 2028

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 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: * Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months. * Have least 1 core clinical feature of dementia with Lewy bodies (DLB). * Have a score ≥20 on Montreal Cognitive Assessment (MoCA). * Meet plasma P-tau217 criteria. * Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology. * Have a CSF result consistent with the presence of alpha-synuclein pathology. * Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. Exclusion Criteria: * Have a disease or condition that could interfere with this study or is a current serious or unstable illness. * Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study. * Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study. * Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions. * Have previously received amyloid-targeting therapy. * Active immunization against amyloid-beta. * Have a centrally read MRI that does not meet study entry criteria. * Have contraindication to MRI or PET scans. * Have any contraindication to lumbar puncture.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease amyloidosis brain disorder Cognition Disorders cognitive disorder Cognitive Dysfunction Lewy body dementia Lewy Body Disease nervous system disorder neurodegenerative disease synucleinopathy

As listed by the trial registrant

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

Amyloid Cognitive dysfunction Lewy body disease Synucleinopathies

How to take part

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

  1. The places running it

    72 sites in 4 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

  • Axiom Brain Health LLC

    RECRUITING

    Tampa, Florida, 33609, United States

  • BRP-Kendal Lakes

    RECRUITING

    Miami, Florida, 33175, United States

  • Brain Matters Research

    RECRUITING

    Delray Beach, Florida, 33445, United States

  • CenExel Rocky Mountain Clinical Research

    NOT_YET_RECRUITING

    Englewood, Colorado, 80113, United States

  • Central Texas Neurology Consultants

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Chang Gung Medical Foundation-Linkou Branch

    NOT_YET_RECRUITING

    Taoyuan, 333, Taiwan

  • Charter Research - Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Citizens Memorial Hospital District

    RECRUITING

    Bolivar, Missouri, 65613, United States

  • Conquest Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • EvergreenHealth

    NOT_YET_RECRUITING

    Kirkland, Washington, 98034, United States

  • Ewha Womans University Mokdong Hospital

    NOT_YET_RECRUITING

    Seoul, 07985, South Korea

  • Gachon University Gil Medical Center

    NOT_YET_RECRUITING

    Namdong-gu, 21565, South Korea

  • Gadolin Research

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Gangnam Severance Hospital, Yonsei University Health System

    NOT_YET_RECRUITING

    Gangnam-gu, 06273, South Korea

  • Hanyang University Seoul Hospital

    NOT_YET_RECRUITING

    Seoul, 04763, South Korea

  • Headlands Eastern MA LLC

    RECRUITING

    Plymouth, Massachusetts, 02360, United States

  • HonorHealth Research Institute

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Houston Methodist Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Hyogo Prefectural Harima-Himeji General Medical Center

    RECRUITING

    Himeji, 670-8560, Japan

  • Inage Neurology and Memory Clinic

    RECRUITING

    Inage, 263-0043, Japan

  • Indiana University Health Neuroscience Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inha University Hospital

    NOT_YET_RECRUITING

    Incheon, 22332, South Korea

  • Irvine Clinical Research

    RECRUITING

    Irvine, California, 92614, United States

  • JEM Research Institute

    RECRUITING

    Atlantis, Florida, 33462, United States

  • Juntendo Tokyo Koto Geriatric Medical Center

    NOT_YET_RECRUITING

    Kōtoku, 136-0075, Japan

  • K2 Medical Research - Foxborough

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • K2 Medical Research ORLANDO

    RECRUITING

    Maitland, Florida, 32751, United States

  • Katayama Medical Clinic

    RECRUITING

    Kurashiki, 710-0813, Japan

  • Kerwin Medical Center

    RECRUITING

    Dallas, Texas, 75231, United States

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    NOT_YET_RECRUITING

    Stamford, Connecticut, 06905, United States

  • Kobe University Hospital

    RECRUITING

    Kobe, 650-0017, Japan

  • Konkuk University Medical Center

    NOT_YET_RECRUITING

    Seoul, 05030, South Korea

  • Massachusetts General Hospital - Charlestown

    NOT_YET_RECRUITING

    Charlestown, Massachusetts, 02129, United States

  • Mayo Clinic in Florida

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic in Rochester, Minnesota

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memory Clinic Ochanomizu

    RECRUITING

    Bunkyō City, 113-0034, Japan

  • Memory Clinic Toride

    NOT_YET_RECRUITING

    Toride, 302-0004, Japan

  • Nagoya Ekisaikai Hospital

    NOT_YET_RECRUITING

    Nagoya, 454-8502, Japan

  • Nagoya University Hospital

    NOT_YET_RECRUITING

    Nagoya, 466-8560, Japan

  • National Center for Geriatrics and Gerontology

    RECRUITING

    Ōbu, 474-8511, Japan

  • National Cheng Kung University Hospital

    NOT_YET_RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    NOT_YET_RECRUITING

    Taipei, 10002, Taiwan

  • Neurology Center of New England

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Neuropsychiatric Research Center of Southwest Florida

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • New Taipei Municipal TuCheng Hospital

    NOT_YET_RECRUITING

    New Taipei City, 236, Taiwan

  • Nippon Medical School Musashi Kosugi Hospital

    NOT_YET_RECRUITING

    Kawasaki, 211-8533, Japan

  • Norman Fixel Institute for Neurological Diseases (FIND)

    NOT_YET_RECRUITING

    Gainesville, Florida, 32608, United States

  • Oita University Hospital

    NOT_YET_RECRUITING

    Yufu, 879-5593, Japan

  • Oregon Health and Science University

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Palm Beach Neurology

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Pennsylvania Hospital

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Profound Research LLC

    RECRUITING

    Carlsbad, California, 92011, United States

  • QUEST Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Re:Cognition Health

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34471, United States

  • Shonan Keiiku Hospital

    NOT_YET_RECRUITING

    Fujisawa, 252-0816, Japan

  • St. Marianna University Hospital

    NOT_YET_RECRUITING

    Kawasaki, 216-8511, Japan

  • Stanford Neuroscience Health Center

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • Struthers Parkinson's Center

    NOT_YET_RECRUITING

    Golden Valley, Minnesota, 55427, United States

  • Summit Headlands

    RECRUITING

    Portland, Oregon, 97210, United States

  • Tachikawa Hospital

    NOT_YET_RECRUITING

    Tachikawa, 190-8531, Japan

  • Taipei Medical University Shuang Ho Hospital

    NOT_YET_RECRUITING

    New Taipei City, 235, Taiwan

  • Taipei Veterans General Hospital

    NOT_YET_RECRUITING

    Taipei, 11217, Taiwan

  • The University of Kansas - Clinical Research Center

    NOT_YET_RECRUITING

    Fairway, Kansas, 66205, United States

  • The University of Osaka Hospital

    NOT_YET_RECRUITING

    Suita, 565-0871, Japan

  • The University of Texas Health Science Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The University of Texas Health Science Center at Houston

    NOT_YET_RECRUITING

    Houston, Texas, 77054, United States

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    NOT_YET_RECRUITING

    tabashi City, 173-0015, Japan

  • TrialSphere Corp

    RECRUITING

    Chandler, Arizona, 85286, United States

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • VIN - Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • Yokohama Minami Kyosai Hospital

    NOT_YET_RECRUITING

    Yokohama, 236-0037, Japan

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