NCT07012993 Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
| NCT ID | NCT07012993 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akiva Mintz |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-05-20 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; Ability to provide informed consent and comply with study procedures; For female participants: Must not be pregnant or breastfeeding; Negative pregnancy test required for women of childbearing potential. Exclusion Criteria: Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 millisievert \[mSv\] total); More than four prior enrollments in this study; Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan; Pregnant or breastfeeding individuals (negative pregnancy test required); Inability to provide informed consent; Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07012993 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07012993 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07012993 currently recruiting?
Yes, NCT07012993 is actively recruiting participants. Contact the research team at bblanchfield@nii.org for enrollment information.
Where is the NCT07012993 trial being conducted?
This trial is being conducted at Englewood, United States.
Who is sponsoring the NCT07012993 clinical trial?
NCT07012993 is sponsored by Akiva Mintz. The trial plans to enroll 200 participants.
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