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Can a new drug slow Alzheimer's? major study launches

NCT ID NCT06566170

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether adding the drug donanemab to standard care helps people with early Alzheimer's stay independent longer. Researchers will follow about 6,250 participants for over 5 years, tracking when they need more help with daily tasks. The goal is to see if donanemab can slow the disease's progression in real-world settings.

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.

Participants

About 6,250 people

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

Started

Oct 2024

Expected to finish

Feb 2033

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.

Who is studied

The study population will consist of a donanemab plus usual care group and a usual care alone group. Participants will be enrolled 1:2 into donanemab plus usual care and usual care alone groups to allow enough participants in the usual care group to be matched with participants in the donanemab group to enable robust comparative effectiveness analyses.

Ages

60 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: Participants * are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \[EHR\] is required prior to screening) * have a Telephone Interview for Cognitive Status (TICS) score of ≥21 * presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \[CSF\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry) * have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and * have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study. Exclusion Criteria: * have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted) * have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (\>12 months) institutional-level care, serious psychiatric illness, etc.) * are currently enrolled or intend to enroll in a clinical trial of another investigational product, and * have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

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

Alzheimer disease

How to take part

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

  1. The places running it

    1 site. 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

  • Rehabilitation & Neurological Services

    RECRUITING

    Huntsville, Alabama, 35805-4046, United States

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