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Head-to-Head Harmonization Of Tau Tracers In Alzheimer's Disease (HEAD)

Overview

About this study

The purpose of this study is to compare different ways of measuring tau both in the brain and in the blood over time in healthy controls and individuals with cognitive impairment. We will collect images in healthy elderly people, individuals with mild cognitive impairment and those diagnosed with Alzheimer’s disease to help us learn how the buildup of amyloid and tau proteins may contribute to developing the disease and in normal aging. Healthy young individuals will be used as controls.

This study is composed of 2 timepoints, separated by approximately 18 months. Each timepoint will require visits to the research institution over multiple days.  During these visits, you will receive 3 PET scans, 1 MRI scan, blood draws, and undergo clinical assessments and cognitive testing.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Healthy Young Subjects:

  • 18-25 (inclusive) years of age.

Inclusion Criteria - Cognitively Unimpaired (CU) Elderly Subjects:

  • 50 years of age and above.
  • Have a study partner able to provide an independent evaluation of functioning.
  • MMSE scores between 24-30 (inclusive).
  • Clinical Dementia Rating (CDR) of 0.

Inclusion Criteria - Mild Cognitive Impairment (MCI) Subjects:

  • 50 and above years of age.
  • MCI.
  • Have a study partner able to provide an independent evaluation of functioning.
  • MMSE scores between 24-30 (inclusive).
  • Clinical Dementia Rating (CDR) of 0.5.

Inclusion Criteria - AD Dementia (AD) Subjects:

  • 50 and above years of age.
  • Have a study partner able to provide an independent evaluation of functioning.
  • Mild to moderate AD dementia.
  • MMSE scores between 11-26 (inclusive).
  • Clinical Dementia Rating (CDR) of 0.5 or 2.0.

Inclusion Criteria - Study Partner(s):

  • Must know the participants well.
  • Must have regular contact with them.
  • Must be able to describe their functioning.
  • Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the local site PI and study PIs. 
    • Note:  all US study sites will enroll only English-speaking participants. The Canadian site will enroll both English-speaking and French-speaking participants.

Exclusion Criteria - All Subjects:

  • Inability to complete the PET scans (e.g. claustrophobia, inability to lie still for duration of scans).
  • Pregnancy.
  • Breastfeeding.
  • Inability to complete MRI scan (includes a pacemaker, artificial heart valve, select aneurismal clip, select ear implants, select stents incompatible with 3T MRI, metal fragments or foreign objects in the skin, eyes, or body (dental fillings do not present a risk for MRI), and claustrophobia.

Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Val Lowe, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Amber Stephan

5072662927

stephan.amber@mayo.edu

More information

Publications

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CLS-20535314

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