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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

R21 Roche: 3-Way Tau Tracers in AD

Comparison of 18F-RO948, 18F-MK6240, and 18F-GTP1 Radiopharmaceuticals in Patients With Alzheimer Disease and Older Controls

R21 Roche: 3-Way Tau Tracers in AD (NCT05464368) is a Phase 1 interventional studying Alzheimer Disease, sponsored by Washington University School of Medicine. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and \[18F\]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these three next-generation TAU radioligands and compare each of them with historical data of the current most widely used first generation radioligand, 18F-AV1451. Upto38 (30 AD (Amyloid +)and 8 OC (Amyloid -), matched for age and sex with A+ subjects) male and female subjects aged 50-100 will be enrolled in this study protocol: up to 8 for Cohort 1, up to 8 for Cohort 2, and up to 22 for Cohort 3. The study consists of three cohorts: Cohort 1: Up to8 AD subjects (A+; CDR 0.5 and 1)will receive two PET scans in random order, with receiving either18F-RO948 or18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 2:Up to8 OC (A-; CDR=0)subjects will receive two PET scans in random order, with receiving either18F-RO948or 18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 3:Up to 22 (A+; CDR = 0, .5 and 1) subjects will receive three PET scans in random order, with receiving 18F-RO94818F-MK6240 or18F-GTP1at the first scan. Efforts will be made to include about 1/3 CDR = 0, 1/3 CDR .5, and 1/3 CDR 1 in Cohort 3.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Alzheimer Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 38 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to any study procedures. Subjects deemed incapable of willing to sign a consent form must have willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

[18F]RO-948

Johns Hopkins University has conducted the first in human study in collaboration with Roche for 18F-RO948and found that 18F-RO948isa promising radioligand for imaging tau pathology in AD, showing excellent brain uptake and displaying little off-target binding(22, 17, 34).The injected activity for18F-RO948will be as low as practicable, while still allowing accurate quantification of the PET images.The injected dose of 370MBq(10mCi)has been selected based on the radiation dose estimates for18F-RO948gathered in human subjects provided by Michael Stabin, Ph.D., and in accordance with the principle that radiation doses should be "as low as reasonably achievable". This radiotracer will be manufactured on site in the Mallinckrodt Institute of Radiology Cyclotron Facility, a certified Nuclear Pharmacy.

DRUG

18F-MK6240

18F-MK6240 is an investigational PET radiotracer discovered by Merck Research Laboratories and is being developed by Cerveau Technologies, Inc.,for imaging neurofibrillary tangles (NFTs)in the brains of people withAlzheimerdisease.18F-MK6240 has been reported to exhibit good kinetics with high binding levels to brain regions associated with deposition of neurofibrillary tangles in people with AD(35,36).The tracer has been used to monitor the progression of AD.The injected activity for18F-MK6240 will be as low as practicable, while still allowing accurate quantification of the PET images.The injected dose will be 185MBq(5mCi) has been selected based on the radiation dose estimates gathered in human subjects(37)and in accordance with the principle that radiation doses should be "as low as reasonably achievable." This radiotracer will be manufactured on site in the Mallinckrodt Institute of Radiology Cyclotron Facility, a certified Nuclear Pharmacy.

DRUG

18F-GTP1

18F-GTP1is anInvestigational tau PET radiotracer being developed by Genentech for imaging intraneuronal neurofibrillary tangles in patients with AlzheimerDisease. 18F-GTP1 has been reported to exhibit high affinity and selectively for tau pathology, favorable dosimetry and brain kinetics. Degree of 18F-GTP1-specific binding increased withAD severity, could differentiate diagnostic cohorts, and monitor longitudinal change in tau burden. 18F-GTP1 will be provided from LMI sourced through Illinois or New Jersey certified location.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Washington University School of Medicine
St Louis, Missouri, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05464368), the sponsor (Washington University School of Medicine), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05464368 clinical trial studying?

This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and \[18F\]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these three next-generation TAU radioligands and compare each of them with historical data of the current most widely used first generation radioligand, 18F-AV1451. Upto38 (30 AD (Amyloid +)and 8 OC (Amyloid -), matched for age and sex with A+ subjects) ma… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05464368?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05464368?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05464368. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05464368. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.