Tau PET Outcomes With Anti-amyloid Immunotherapies

NCT06723015 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 24-004371
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment, Mild; Dementia, Mild; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in tau PET Standardized Uptake Value (SUVR)

  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

  Baseline, 18 months

Secondary Outcomes (1)

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

  18 months

Study Arms (2)

Control Group

NO INTERVENTION

Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553).

Treatment Group

EXPERIMENTAL

Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy.

Drug: 18F-AV-1451

Interventions

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..

Treatment Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Lymphoma, Follicular; Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Petrice Cogswell, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)