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RecruitingPhase 1

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)

A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive three intramuscular injections at Weeks 0, 4, and 38, with follow-up visits through Week 58."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests AV-1980R, an experimental vaccine that targets abnormal tau protein linked to Alzheimer's disease. It checks safety, side effects, and the body's immune response at different doses, compared with a placebo. It is for adults ages 65 to 80 who have no memory or thinking problems but have blood test signs of early Alzheimer's disease.

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 65 to 80 years old. Women must be past menopause or have had surgery that prevents pregnancy.
  • Have no memory or thinking problems and meet the study's required scores on thinking tests.
  • Have a blood test showing the required signs of early Alzheimer's disease. A positive test from the past 12 months must be confirmed by the study lab.
  • Be able to see and hear well enough to complete study tasks. Hearing aids are allowed.
  • Take stable medicines. Changing treatments may be allowed if the health condition is controlled.
  • Sign a consent form before study procedures and be able to understand and follow study requirements.

Who can't join

  • Have certain strokes, bleeding, swelling, or other major changes on a brain MRI. Also excluded: being unable to have an MRI because of unsafe metal implants or a serious fear of enclosed spaces.
  • Have had a serious illness needing treatment throughout the body or a hospital stay within 4 weeks before entry. Other major illnesses, surgery, or medical, mental health, or social issues may rule you out if they affect safety or participation.
  • Have diabetes that needs insulin, certain heart rhythm or electrical problems, or an autoimmune disease, where the immune system attacks the body.
  • Score 3 or higher on the study's suicide-risk test or have a seizure disorder. Certain seizure medicines used steadily for long-term pain may be allowed.
  • Have recently used an experimental drug or joined another drug study: within 30 days or 5 drug half-lives, whichever is longer. A half-life is the time for half a drug to leave the body. Other limits include tau or amyloid-beta immune treatment within 1 year, or certain immune-changing or growth-stimulating treatments within 30 days.
  • Have used blood thinners or medicines such as clopidogrel that prevent blood clots for more than 3 months.
  • Have received injected antibody treatments, blood products, or products made from plasma, the liquid part of blood. A history of severe vaccine reactions or major allergic reactions also rules you out.
  • Have important abnormal lab results, including certain liver tests above 1.5 times the normal upper limit, or test positive for HIV, hepatitis B surface antigen, or hepatitis C.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (6)

FL

GA