AzTrials
AzTrials

Alzheimer DiseasePhase 1NCT05464368

R21 Roche: 3-Way Tau Tracers in AD

A Phase 1 study testing [18F]RO-948, 18F-MK6240 and 18F-GTP1 in people with Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 50 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
[18F]RO-948, 18F-MK6240 and 18F-GTP1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Being tested
[18F]RO-948, 18F-MK6240, 18F-GTP1
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]RO-948Drug

    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.

  • 18F-MK6240Drug

    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.

  • 18F-GTP1Drug

    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.

Study groups in NCT05464368
Study groupRoleWhat they receive
Cohort 1: (A+; CDR = .5, 1; AD)ExperimentalUnblinded and randomized to receive either 18F-RO948or 18F-MK6240 for PET Scan #1. PET scan #2 will be either 18F-RO948or 18F-MK6240 NOT received in PET scan #1. If a 3rdPET scanoccurs,this third scanwill always be [18F]GTP1.
Receives: Drug: [18F]RO-948; Drug: 18F-MK6240; Drug: 18F-GTP1
Cohort 2: (A-; CDR=0; OC)ExperimentalUnblinded and randomized to receive either 18F-RO948or 18F-MK6240 for PET Scan #1. PET scan #2 will be either 18F-RO948or 18F-MK6240 NOT received in PET scan#1.If a 3rdPET scan occurs, this third scan will always be [18F]GTP1.
Receives: Drug: [18F]RO-948; Drug: 18F-MK6240; Drug: 18F-GTP1
Cohort 3: (A+; CDR = 0, .5, 1; AD)ExperimentalUnblinded and randomized to receive 18F-RO948or 18F-MK6240 or [18F]GTP1for PET Scan #1. PET scan #2 will be 18F-RO948or 18F-MK6240 or [18F]GTP1NOT received in PET scan #1. PET scan # 3 will be 18F-RO948or 18F-MK6240 or [18F]GTP1NOT received in PET scan #1 or #2. Efforts will be made to include about 1/3 CDR = 0; 1/3 CDR = .5; 1/3 CDR = 1 in Cohort 3. Efforts will also be made to completethe study with about equal numbers of subjects whose PET scan #1 start with each of the three tracers.
Receives: Drug: [18F]RO-948; Drug: 18F-MK6240; Drug: 18F-GTP1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.

    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.

    Measured: 37-44 days

  2. 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.

    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.

    Measured: 37-44 days

  3. 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.

    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.

    Measured: 37-44 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start1 Feb 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Factorial
Model description
Cohort 1Summary: BBBM/Amyloid PET scan A+;CDR .5 or1,Inclusive;arterial lines(N=8) Cohort 2Summary:BBBM/Amyloid PET scan A-;CDR 0;arterial lines; (N=8) Cohort3 Roche Supplement Summary: BBBM/Amyloid PET scan A+; CDR 0,.5 and/or 1(approx. 1/3rdof participants in each CDR score); can shorten total scan time or add break(N=22)
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464368
Sponsor's protocol ID
202204181
Status last verified
May 2026
First submitted
23 Jun 2022
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Share information with NIH according to guidelines.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]RO-948, 18F-MK6240 and 18F-GTP1 in people with Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls. (time frame: 37-44 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in