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Could a vaccine stop Alzheimer's before it starts? new trial begins

NCT ID NCT07158905

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 6 times

Summary

This Phase 1 trial tests an experimental vaccine called AV-1980R that targets tau protein, a key player in Alzheimer's disease. The study enrolls 48 cognitively healthy adults aged 65-80 who have biological signs of early Alzheimer's. Researchers will check if the vaccine is safe and whether it produces antibodies against tau, with the goal of preventing memory loss.

What this could mean

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

Active substance
AV-1980R (tau vaccine)
What this could lead to
If successful, this could lead to a vaccine that prevents Alzheimer's symptoms by targeting tau protein before memory loss begins.
What could go wrong
This is an early Phase 1 safety trial with only 48 people. The vaccine may not trigger a strong immune response or could cause side effects. It is years away from being a proven treatment.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

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

Started

Jun 2026

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 80 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: Male or postmenopausal or surgically sterile female, 65 to 80 years of age, inclusive. Cognitively unimpaired participant with preclinical Alzheimer's disease who meets all of the following: Clinical Dementia Rating global score of 0 at Screening. Mini-Mental State Examination score ≥26, with education adjustment at Screening. Plasma p-tau217/Aβ42 ratio ≥0.00738 measured using Lumipulse (Fujirebio). A prior positive result obtained within 12 months before Screening may be accepted but must be confirmed by the central laboratory. Sight and hearing, including use of a hearing aid, sufficient to comply with study procedures. Stable concomitant medications. Participants receiving fluctuating medication or treatment may be considered if the underlying condition is controlled. Signed informed consent before any study-related procedure. Ability, in the Investigator's opinion, to understand the study and comply with protocol requirements. Exclusion Criteria: Screening MRI showing any of the following: More than one noncortical lacunar infarct greater than 1.5 cm. Any territorial infarct greater than 1.5 cm. Combined microbleeds and areas of leptomeningeal hemosiderosis greater than 5, or disseminated leptomeningeal hemosiderosis. Any other significant cerebral abnormality, including ARIA-E. Contraindication to MRI, including non-MRI-safe implanted metallic devices or clinically significant claustrophobia. Serious illness requiring systemic treatment or hospitalization within 4 weeks before study entry. Clinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, systemic disease, or major surgery that could interfere with participation or follow-up. Insulin-dependent diabetes. Clinically relevant cardiac arrhythmia, palpitation, conduction abnormality, prolonged QT interval, or bundle branch block. Pre-existing autoimmune disease. C-SSRS score of 3 or higher. History of seizure disorder, except permitted stable use of certain antiepileptic medications for chronic pain. Any medical, psychological, or social condition that could interfere with participation, compliance, or participant safety. Participation in another investigational drug study or use of an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing. Prior tau or amyloid-beta immunotherapy within 1 year before Screening. Use of specified immunomodulatory or growth-stimulating treatments within 30 days before study entry. Chronic use for more than 3 months of warfarin, other coumarin derivatives, anticoagulants, or an antiplatelet agent such as clopidogrel. Parenteral immunoglobulin preparations, blood products, or plasma derivatives. History of severe local or systemic vaccination reactions or significant allergic reactions. Clinically significant laboratory abnormalities at Screening, including ALT or AST greater than 1.5 times the upper limit of normal. Positive testing for HIV-1 or HIV-2, hepatitis B surface antigen, or hepatitis C.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 sites. 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

  • Alzheimer's Research and Treatment Center (Columbus)

    RECRUITING

    Columbus, Georgia, 31904, United States

  • Alzheimer's Research and Treatment Center (Stuart)

    RECRUITING

    Stuart, Florida, 34996, United States

  • Alzheimer's Research and Treatment Center (Wellington)

    RECRUITING

    Wellington, Florida, 33414, United States

  • Comprehensive Center for Brain Health

    RECRUITING

    Boca Raton, Florida, 33433, United States

  • Palm Springs Community Health Center

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

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