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New PET tracers tested to spot Alzheimer's tau tangles

NCT ID NCT05464368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests three new imaging agents (18F-RO948, 18F-MK6240, and 18F-GTP1) to see how well they detect tau protein buildup in the brains of people with Alzheimer's disease compared to healthy older adults. About 38 participants aged 50-100 will receive PET scans to compare these tracers. The goal is to improve diagnosis by finding which tracer works best and has fewer false signals.

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 38 people

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

Started

Feb 2023

Expected to finish

Jun 2027

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

50 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 and female subjects 50 to 100 years of age: Female subjects must be either surgically sterile or post-menopausal for at least 1 year or, Women of child bearing potential must commit to use a barrier contraception method for the duration of the study in addition to either an intra uterine device or hormonal contraception started at least 1 month prior to the first dose of radiotracer and until follow-up. Male subjects and their partners of childbearing potential must agree to use an effective method of contraception and will not donate sperm during the study. Barrier method must include use of a spermicide. * Subjects who sign an IRB approved informed consent prior to any study procedures. Subjects deemed incapable of informed consent must have informed consent provided by a legally authorized representative. For AD subjects, capacity for consent will be determined using the Alzheimer Disease Research Center's questions * Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures,and can safely tolerate tracer administration and the scanning procedures. * If subjects are on any concomitant medication, the indication and dosage of these medicines should be stable for at least 4 weeks prior to study start with the expectation that no relevant changes in use or dose will occur throughout the trial. * Body mass index BMI between 18 and 32 kg per m2, Body weight less than 300 pounds * Older Controls must have normal cognitive function, including a normal CDR = 0 as judged by the investigator for OC. * AD subjects must have a diagnosis of probable AD, according to the National Institute of Neurological and Communicative Disorders and Stroke Alzheime rDisease and Related Disorders Association criteria with a CDR \>0 to 1 and positive CSF or amyloid PET Scan. * AD subjects must have a reliable person able to accompany the subject to all visits and answer questions about the subject. * AD subjects must have a positive florbetapiro, amyloid blood-based biomarkers(BB BM), or amyloid-beta and tau CSF levels, which in the opinion of the principal investigator is consistent with a diagnosis of AD. Exclusion Criteria: * History or presence of a neurological diagnosis other than AD that may influence the outcome or analysis of the scan results; examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer tauopathies, and Parkinson's disease. * Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein APP or presenilin PS1, PS2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., tau MAPT * History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or CNS disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator. * Clinically relevant pathological findings in physical examination, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the study. * Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV infection. * Women of childbearing potential must not be pregnant, or nursing and serum human chorionic gonadotropin HCG must be negative at the time of Screening Visit, and urine HCG must be negative on all subsequent visits. * Loss or donation of more than 450 mL blood in the 4 months before screening or donation of plasma within 14days of screening or history of bleeding disorder or presence of anticoagulants * Current symptoms of allergy and or severe allergy to drugs in medical history. * History of drug or alcohol abuse or positive result from urine screen for drugs of abuse. AD subjects on prescribed narcotics medications will not be excluded if urine drug screen is positive for the documented narcotic drugs. * Have received an investigational medication within the last 3 months or 5 elimination half-life, whichever is longer, prior to administration of the radiotracer. * Has had or is planning to have exposure to ionizing radiation that in combination with the study related tracer administrations and scanning procedures would result in a cumulative exposure that exceeds 5.0 rem over a 12-month period of time. * Contraindications of previous or study screening MRI * History of, or suffers from, claustrophobia or feels that he or she will be unable to lie still on their back in the MRI or PET scanner. * Subjects with hearing impairment, illiteracy, non-English speakers, or English as a second-language (since there is no direct medical benefit to participants). * Subjects who have not completed at least 2 COVID-19 vaccination injections.16. Subjects who will not wear mask over nose and mouth during all visits except

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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.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.