Tau PET Outcomes with Anti-amyloid Immunotherapies

Phase 2

• Conditions: Cognitive Impairment, Mild; Dementia, Mild; Alzheimer Disease
• Interventions: Drug: 18F-AV-1451

• Registration Number: NCT06723015
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Study Start: 2025-08
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	18F-AV-1451	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.

Primary Outcome Measures

Name	Time	Method
Change in tau PET Standardized Uptake Value (SUVR)	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 Outcome Measures

Name	Time	Method
Number of subjects to develop amyloid-related imaging abnormalities (ARIA)	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States