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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 0 days
Treatment Varies
Follow Up 0 days
Awards & highlights
No Placebo-Only Group
Summary
This trial uses special imaging agents to help visualize harmful brain proteins in people at risk of Alzheimer's disease. The agents make these proteins glow during scans, allowing doctors to see them clearly and monitor the disease.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to have multiple MR/PET scans.
Timeline
Screening ~ 0 days1 visit
Treatment ~ Varies
Follow Up ~ 0 days5 visits
Screening ~ 0 days
Treatment ~ Varies
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cross-sectional tau PET uptake values
Longitudinal change in tau PET uptake values over 18 months
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and tau PET radiopharmaceuticals. Cholinesterase inhibitors, such as donepezil, rivastigmine, and galantamine, increase cholinergic transmission by inhibiting the enzyme cholinesterase, leading to modest improvements in cognition and global functioning.
Tau PET radiopharmaceuticals like Flortaucipir and MK-6240 are used to measure tau tangles, a key feature of AD pathology, aiding in diagnosis and monitoring disease progression. These treatments are important as they help manage symptoms and track the effectiveness of therapeutic interventions in AD patients.
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
1,799 Previous Clinical Trials
28,192,811 Total Patients Enrolled
Tharick Pascoal, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Alzheimer's Disease.You are willing and able to have multiple MRI/PET scans done.You have an informant who will be able to provide an independent evaluation of functioning.I am between 50 and 90 years old.I am willing and able to have multiple MR/PET scans.I am unable to give consent for treatment myself or through someone else.I don't have any health issues or take medications that could affect the study.You are willing and able to have multiple MR/PET scans.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals across the aging and Alzheimer's disease (AD) spectrum
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 0 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05361382 — Phase 1