Could a vaccine stop Alzheimer's before it starts? new trial begins
NCT ID NCT07158905
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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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
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65 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Alzheimer's Research and Treatment Center (Columbus)
RECRUITINGColumbus, Georgia, 31904, United States
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Alzheimer's Research and Treatment Center (Stuart)
RECRUITINGStuart, Florida, 34996, United States
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Alzheimer's Research and Treatment Center (Wellington)
RECRUITINGWellington, Florida, 33414, United States
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Comprehensive Center for Brain Health
RECRUITINGBoca Raton, Florida, 33433, United States
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Palm Springs Community Health Center
RECRUITINGMiami Lakes, Florida, 33014, United States
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University of South Florida
RECRUITINGTampa, Florida, 33613, United States
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