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Radiopharmaceutical

Tau Tracer Comparison for Alzheimer's Disease (HEAD Trial)

Phase 1
Recruiting
Led By Tharick Pascoal, MD PhD
Research Sponsored by Tharick Pascoal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and capable of undergoing repeated MR/PET imaging.
Fluent in a language approved by the coordinating center.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years from enrollment
Awards & highlights

HEAD Trial Summary

This trial is comparing two different ways of measuring tau in the brain to see which is more accurate.

Who is the study for?
This trial is for people aged 50-90 with no cognitive impairment, mild cognitive impairment, or Alzheimer's disease. They must be able to undergo repeated MR/PET imaging and have someone who can report on their functioning. Pregnant women and those unable to consent or at increased risk due to other conditions/medications are excluded.Check my eligibility
What is being tested?
The study aims to compare tau PET radiopharmaceuticals Flortaucipir and MK-6240 in measuring tau tangles in the brain related to Alzheimer's. It will help understand how these tracers can be used in clinical settings by integrating their estimates.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the imaging process, allergic reactions to tracers, and temporary side effects from radiation exposure such as nausea.

HEAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing and able to have multiple MR/PET scans.

HEAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cross-sectional tau PET uptake values
Longitudinal change in tau PET uptake values over 18 months
Secondary outcome measures
Associations of tau PET uptake values blood biomarkers
Associations of tau PET uptake values with amyloid-β PET uptake values
Associations of tau PET uptake values with measures of cognition

HEAD Trial Design

1Treatment groups
Experimental Treatment
Group I: Individuals across the aging and Alzheimer's disease (AD) spectrumExperimental Treatment3 Interventions
Approximately 620 individuals (40 young healthy, 280 cognitively unimpaired older, 200 mild cognitive impairment, and 100 Alzheimer's disease dementia) will be enrolled in the HEAD study.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Tharick PascoalLead Sponsor
National Institute on Aging (NIA)NIH
1,676 Previous Clinical Trials
28,020,879 Total Patients Enrolled
Tharick Pascoal, MD PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

18F-Flortaucipir radiopharmaceutical (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05361382 — Phase 1
Alzheimer's Disease Research Study Groups: Individuals across the aging and Alzheimer's disease (AD) spectrum
Alzheimer's Disease Clinical Trial 2023: 18F-Flortaucipir radiopharmaceutical Highlights & Side Effects. Trial Name: NCT05361382 — Phase 1
18F-Flortaucipir radiopharmaceutical (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361382 — Phase 1
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05361382 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What magnitude of risk is associated with the Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694)?

"Our team at Power has evaluated the safety of Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694) as a 1, given that this is an early stage trial and there is limited evidence on its efficacy."

Answered by AI

Are there any limitations on who can participate in this clinical research?

"This medical study is seeking 620 volunteers between the ages of 20 and 90 with a confirmed diagnosis of Alzheimer's disease. Other criteria for participation include having an informant that can provide independent evaluation, willingness to undergo multiple MR/PET scans, fluency in approved languages, and no cognitive impairment at screening or meeting mild-cognitive impairment or dementia requirements."

Answered by AI

In what geographic areas is this research project being conducted?

"Eight cities are hosting this clinical trial, including Saint Louis, San Francisco and Pittsburgh. To reduce any potential travel burden to participants, they should select the closest site available."

Answered by AI

Does the criteria for this research exclude elderly individuals?

"This clinical trial has been designed to include participants that are between 20 and 90 years of age. There also appear 23 other trials for minors and 536 studies focused on elderly patients."

Answered by AI

How many participants are registered to take part in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov corroborates that this study is vigorously recruiting for candidates; the initial posting was made November 23rd 2021, and it has recently been updated November 7th 2022. 620 patients are required from 8 distinct medical institutions."

Answered by AI

Are there any vacancies available for individuals to take part in this research?

"According to the details provided on clinicaltrials.gov, this investigation is still open for patient recruitment and was initially made available on November 23rd 2021 with a recent update posted in November 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
Rhode Island
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Washington University in St. Louis
McGill University Research Centre for Studies in Aging
Brown University

What questions have other patients asked about this trial?

How long do screening visits take? How often would I need to come in for screenings? Would I be able to see the results of my screenings and go over them with a neurologist?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I am a 71 year old, otherwise healthy woman who was diagnosed with Alzheimer's several.
PatientReceived 1 prior treatment
I am a 71 year old, otherwise healthy woman who was diagnosed with Alzheimer's several months ago. I would like to slow down this process if possible. I'd also like to be a part of finding a cure.
PatientReceived no prior treatments
From another study I have learned that I have elevated amyloid plaque in my brain. I would like to know more about the level of tau in my brain as I understand tau is linked more closely to cognitive decline. With this knowledge it might help me to understand the stage of my disease and when I might want to consider doing a drug trial.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Brown University: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease
Tharick Pascoal 2021. "Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361382.
All > Alzheimers Disease Boston
~338 spots leftby May 2027
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