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Alzheimer DiseasePhase 1HEADNCT05361382

Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease

A Phase 1 study testing 18F-Flortaucipir radiopharmaceutical, 18F-MK-6240 radiopharmaceutical and Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol) in people with Alzheimer Disease, run by Tharick Pascoal at 9 sites in 3 countries.

Active, not recruiting

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

Official record
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Trial summary

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
18F-Flortaucipir radiopharmaceutical, 18F-MK-6240 radiopharmaceutical and Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
822 participants
Where
9 sitesin 3 countries
Study dates
2 Mar 2022to 31 May 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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Have a study partner who will be able to provide an independent evaluation of functioning.
  • Willing and capable of undergoing repeated MR/PET imaging.
  • Fluent in a language approved by the coordinating center.
  • At screening, must have no cognitive impairment, or meet criteria for single- or multiple-domain amnestic mild cognitive impairment or Alzheimer's disease dementia.

Who cannot join

  • Inability to provide informed consent by self or by proxy.
  • Pregnant or breastfeeding women.
  • Have any condition or are taking any medication that could increase the risk to the participant, limit the ability to tolerate or interfere with the results of the tests and procedures (in the opinion of the investigator).

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States7 sites

  • Lawrence Berkeley National Laboratory

    Berkeley, California, 94720

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

  • Brown University

    Providence, Rhode Island, 02912

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California San Francisco

    San Francisco, California, 94143

  • Washington University in St. Louis

    St Louis, Missouri, 63130

Other trials in United States

Canada1 site

  • McGill University

    Montreal, Quebec, H3A 0G4

Other trials in Canada

Spain1 site

  • Sant Pau Biomedical Research Institute

    Barcelona, Spain, 08025

Other trials in Spain

About this study

Official title: Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

Read the detailed description

This is a longitudinal, multi-site, non-randomized study in which the participants will undergo Flortaucipir and MK-6240 PET scans at baseline and approximately at 18-month follow-up. At each time point, participants will also have an amyloid-β PET scan, magnetic resonance imaging, detailed cognitive tests, and a blood draw for biomarker quantification. The main objectives of this study are standardizing tau PET tracers' outcomes and comparing their performance.

To accomplish our objectives, the investigators propose the following specific aims:

In Aim 1, investigators will standardize tau PET processing methods, convert the tracers to a common scale, compare associations with amyloid-β, atrophy, and cognition, and compare/harmonize Braak staging assessments between tau tracers using cross-sectional data.

In Aim 2, investigators will ascertain the optimal processing method for longitudinal analysis and compare longitudinal changes in tau accumulation obtained with the tau PET radiopharmaceuticals and their associations with changes in amyloid-β, atrophy, and cognition.

In Exploratory Aim 3, investigators will compare cross-sectional and longitudinal Flortaucipir and MK-6240 estimates with plasma phosphorylated tau concentrations.

This study will produce a benchmark dataset to develop methods for tau PET quantification and harmonization.

Being tested
18F-Flortaucipir radiopharmaceutical, 18F-MK-6240 radiopharmaceutical, Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)
Keywords
Tau PET, Neurofibrillary tangles, Alzheimer's disease, Tauopathies, Biomarkers
Medical subject headings
Alzheimer Disease, Tauopathies

What participants receive

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

  • 18F-Flortaucipir radiopharmaceuticalDrug

    Also called 18F-AV-1451, 18F-T807, Tauvid

    Flortaucipir is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 10 millicuries of the radiopharmaceutical.

  • 18F-MK-6240 radiopharmaceuticalDrug

    MK-6240 is a PET radiopharmaceutical that binds to tau neurofibrillary tangles. Participants will receive a bolus intravenous injection of approximately 5 millicuries of the radiopharmaceutical.

  • Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)Drug

    The clinical sites will use either PiB, Florbetaben, Flutemetamol, or NAV-4694 as the amyloid-β PET radiopharmaceutical. The amyloid-β PET radiopharmaceutical binds to amyloid-β plaques.

    Participants will receive a bolus intravenous injection of approximately 15 millicuries of the PiB radiopharmaceutical.

    Participants will receive a bolus intravenous injection of approximately 8 millicuries of the Florbetaben or NAV-4694 radiopharmaceutical.

    Participants will receive a bolus intravenous injection of approximately 5 millicuries of the Flutemetamol radiopharmaceutical.

Study groups in NCT05361382
Study groupRoleWhat they receive
Individuals across the aging and Alzheimer's disease (AD) spectrumExperimentalAll individuals enrolled into the HEAD study will undergo tau PET, amyloid-β PET, magnetic resonance imaging (MRI), detailed clinical and cognitive assessment, and a blood draw.
Receives: Drug: 18F-Flortaucipir radiopharmaceutical; Drug: 18F-MK-6240 radiopharmaceutical; Drug: Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol)

What is being measured

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

  1. Cross-sectional tau PET uptake values

    Compare/harmonize cross-sectional tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240.

    Measured: 2 years from enrollment

  2. Longitudinal change in tau PET uptake values over 18 months

    Compare/harmonize change in tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 between baseline and 18-month follow-up assessments.

    Measured: 5 years from enrollment

Secondary outcomes (3)

  1. Associations of tau PET uptake values with amyloid-β PET uptake values

    Compare the effect size of the associations of tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 with amyloid-β deposition measurements (SUVR).

    Measured: 5 years from enrollment

  2. Associations of tau PET uptake values with measures of cognition

    Compare the effect size of the associations of tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 with cognitive measures assessed from neuropsychological evaluation.

    Measured: 5 years from enrollment

  3. Associations of tau PET uptake values blood biomarkers

    Compare the effect size of the associations of tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 with blood-based biomarkers of tau.

    Measured: 5 years from enrollment

Timeline

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

  1. First posted4 May 2022
  2. Study start2 Mar 2022
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
822 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05361382
Sponsor's protocol ID
STUDY22020056
Other IDs
R01AG073267
Acronym
HEAD
Status last verified
Sep 2026
First submitted
29 Apr 2022
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this research will be shared with other researchers pursuant to the 02/26/2003 "NIH Final Statement on Sharing Research Data". To protect participants' rights and confidentiality, identifiers will be removed from the data before they are shared. The board of PIs has primary oversight of the HEAD study resource sharing plan and will review all issues related to internal and external requests for HEAD data. Raw PET and MR data will be uploaded by clinical sites after acquisitions, whereas processed PET and MR data will be uploaded after completion of the baseline visit and after completion of the 18-month follow-up visit. Demographics, results from cognitive tests, Aβ status, tau Braak staging, and plasma assay results will also be available through the LONI platform.

Publications

  • Povala G, Bellaver B, Lussier FZ, Amaral L, Bauer-Negrini G, Ferreira PCL, Rocha A, Ruppert E, Medeiros MS, Tissot C, Jagust WJ, Masdeu JC, Fortea J, Tudorascu DL, Soleimani-Meigooni DN, Lowe V, Oh H, Pascual B, Gordon BA, Rosa-Neto P, Baker S, Pascoal TA; HEAD Study. Comparison of [18F]flortaucipir and [18F]MK6240 for the detection of tau pathology in Alzheimer's disease (HEAD): a multicentre, prospective, cross-sectional, within-participant study. Lancet. 2026 May 30;407(10544):2217-2226. doi: 10.1016/S0140-6736(26)00417-4.

    PubMed 42208563

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 18F-Flortaucipir radiopharmaceutical, 18F-MK-6240 radiopharmaceutical and Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol) in people with Alzheimer Disease, run by Tharick Pascoal at 9 sites in 3 countries.

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 4 inclusion and 3 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada, Spain. 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?

Cross-sectional tau PET uptake values (time frame: 2 years from enrollment). The study lists 2 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 NCT05361382, which also lists 1 linked publication.

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 Sep 2026.

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