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:

Inclusion Criteria for young healthy subjects:

18-28 (inclusive) years of age.

Inclusion Criteria for cognitively unimpaired (CU) elderly subjects:

50-90 (inclusive) years of age;
Have a study partner able to provide an independent evaluation of functioning.

Inclusion Criteria for mild cognitive impairment (MCI) subjects:

50-90 (inclusive) years of age;
MCI;
Have a study partner able to provide an independent evaluation of functioning.

Inclusion Criteria for ADdementia (AD) subjects:

50-90 (inclusive) years of age;
Mild to moderate AD dementia;
Have a study partner able to provide an independent evaluation of functioning.

Exclusion Criteria:

Inability to complete the PET scans (e.g., claustrophobia, inability to lie still for duration of scans).
Pregnancy.
Breastfeeding.
Inability to complete the MRI scan (e.g., claustrophobia, 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]).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/3/24. 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 M.P.A. (507) 266-2927 Stephan.Amber@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Val Lowe, M.D.

Closed-enrolling by invitation

Contact information:

Amber Stephan M.P.A.

(507) 266-2927

Stephan.Amber@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials