NCT07012993

Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol

Evaluation of Ultralow Dose PET Imaging for Detecting Amyloid Tracer Uptake

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Akiva Mintz · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate an investigational ultralow dose Positron Emission Tomography (PET) imaging technique for Alzheimer's disease, mild cognitive impairment, other forms of dementia detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called Fluorine-18 (18F)-Florbetapir or 18F-Flutemetamol and be imaged on a new type of high-sensitivity PET scanner for up to 3 hours

Detailed description

This research study aims to evaluate an investigational ultralow dose PET imaging technique for Alzheimer's disease, mild cognitive impairment, other forms of dementia detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the U.S. Food and Drug Administration (FDA) for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracers are FDA-approved for detecting amyloid plaque that is found in Alzheimer's Disease at standard doses, but at a much higher dose than is being investigated in this protocol. 18F-Florbetapir and 18F-Flutemetamol are often found to be taken up at higher levels in Alzheimer's disease, mild cognitive impairment, other forms of dementia. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Alzheimer's disease, mild cognitive impairment, other forms of dementia. Investigators will enroll individuals with and without Alzheimer's disease, mild cognitive impairment, other forms of dementia to evaluate how ultralow dose PET imaging detects radiotracer uptake in different types of tissue. Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Dementia
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	18F-Florbetapir or 18F-Flutemetamol	Participants will be injected with 18F-Florbetapir or 18F-Flutemetamol and imaged for up to 3 hours on a PET scanner

Timeline

• Start date: 2025-05-20
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-06-10
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study