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Comparing Tau Tracers in Alzheimer's Disease

This study is comparing three new imaging agents, called 18F-RO948, 18F-MK6240, and 18F-GTP1. These agents help doctors see "tau pathology" (tangles of proteins in the brain) which is a sign of Alzheimer's disease. The study wants to see how well these new agents work in people with Alzheimer's disease and in healthy older adults, and if they are better than an older imaging agent. You might be able to join if you are between 50 and 100 years old. The study will be successful if these new agents can clearly show tau pathology and if their results match whether a person has amyloid (another protein linked to Alzheimer's). The current recruitment status is unclear.

Study design
This is an open-label study, meaning both you and the study team will know which imaging agent you receive. It plans to enroll up to 38 participants, including people with Alzheimer's disease and healthy older adults.
What's involved
The study measures outcomes at 37-44 days. It is not specified how many visits or procedures are involved.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 37-44 days, which suggests a follow-up period within that timeframe.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05464368

R21 Roche: 3-Way Tau Tracers in AD

Active, Not Recruiting
PHASE1Ages 50+InterventionalDiagnostic
Washington University School of Medicine
~38 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:[18F]RO-94818F-MK624018F-GTP1

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.
Measured over 37-44 days
+2 more outcomes measured

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's DiseaseAmyloid beta peptideMicrotubule-Associated Protein Tau

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Tammie L.S. Benzinger · PRINCIPAL_INVESTIGATOR · Hugh Monroe Wilson Professor of Radiology, Professor of Neurological Surgery

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.37-44 days

    Amyloid positivity will be measured by either PET or CSF or blood-based biomarker (BBBM). Investigators will analyze the correlation between image quality and amyloid positivity to support any conclusions that will determine if 18F-MK6240 or 18F-RO948 has better discrimination between Amyloid + and Amyloid - subjects.

  • Imaging capability of 18F-RO948, 18F-MK6240 and 18F-GTP1 in patients with Alzheimer disease or positive memory or thinking problem CDR assessment, and amyloid negative older healthy controls, as compared to 18F-AV1451.37-44 days

    Using 18F-RO948, 18F-MK6240, and \[18F\]GTP1 for imaging of taupathy in patients with Alzheimer's disease (AD) and older healthy controls (OC), investigators will directly compare images and amyloid positivity (Outcome 1) of AD and OC to determine discrimination ability. Investigators will compare all images and amyloid positivity of AD and OC to data gathered using 18F-AV1451 to determine if the new radiotracers are able to outperform this well-known tracer.

  • Correlation between imaging capability of 18F-RO948, 18F-MK6240 and 18F-GTP1 and amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.37-44 days

    Investigators will compare the quality of images to the previously measured amyloid positivity to support any conclusions that will determine if 18F-MK6240 or 18F-RO948 has better discrimination between Amyloid + and Amyloid - subjects.