Tau PET Outcomes With Anti-amyloid Immunotherapies

This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.

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Key information

Conditions

Cognitive Impairment, Mild Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 50-90 years
Male or female
Mild cognitive impairment due to AD or mild AD
Amyloid positive via CSF or PET
Meets other eligibility criteria for anti-amyloid immunotherapy
Subject or delegate provides informed consent

Exclusion criteria

Subjects unable to lie down without moving for 10 minutes.
Women who are pregnant or cannot stop breast feeding for 24 hours.
Claustrophobic patients unable to tolerate the scans (no sedation can be offered).

Treatment and study plan

18F-AV-1451

Drug

Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection.

Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment..

Primary outcomes

Change in tau PET Standardized Uptake Value (SUVR)

Time frame: Baseline, 18 months

A PET Standardized Uptake Value (SUV) is measured by calculating the ratio of the radioactivity concentration within a specific region of interest (ROI) on a PET scan, divided by the injected dose of the radiotracer per unit of the patient's body weight. The calculated Standardized Uptake Value (SUVR) is reported as a single number, with higher values indicating greater tracer uptake in the target region relative to the reference region

Secondary outcomes

Number of subjects to develop amyloid-related imaging abnormalities (ARIA)

Time frame: 18 months

ARIA is defined as edema (parenchymal edema or sulcal effusion, ARIA-E) and hemorrhage (microhemorrhages and superficial siderosis, ARIA-H). ARIA is detected on the patient's routine clinical brain MRIs.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Dec 9, 2024
Registry last updated: Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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