Ultralow Dose PET Imaging for Dementia

Overseen By Barbara Blanchfield

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Akiva Mintz

Disqualifiers: Radiation exposure, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using PET scans, imaging tests that help doctors view the brain, to detect and monitor Alzheimer's and other forms of dementia. The researchers aim to reduce the radiation dose by 10 to 100 times compared to current methods, enhancing patient safety. Participants will receive a small amount of a radioactive tracer, such as 18F-Florbetapir or 18F-Flutemetamol, and undergo brain scans for up to three hours. Individuals diagnosed with mild cognitive issues or dementia who can tolerate a long scan might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in dementia care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this ultralow dose PET imaging technique is safe for dementia detection and monitoring?

Studies have shown that both 18F-Florbetapir and 18F-Flutemetamol are used in PET brain scans to detect amyloid plaques, often found in Alzheimer's disease and other types of dementia. The FDA has approved these imaging agents for use in adults, indicating their safety when used correctly.

For 18F-Florbetapir, also called Amyvid, research has not identified major safety issues when used in brain scans. It has effectively aided in diagnosing conditions like Alzheimer's. Similarly, 18F-Flutemetamol, known as Vizamyl, has been tested in over 800 people, with most side effects reported as mild, such as headache, nausea, and dizziness.

Since this trial is in phase 2, researchers are still carefully observing how well these agents are tolerated at very low doses. However, past use suggests they are generally safe for imaging purposes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultralow dose PET imaging for dementia because it drastically reduces the radiation exposure compared to traditional PET scans. This technique uses a significantly smaller amount of radiotracer, cutting radiation doses by 10 to 100 times, making it safer for patients. Additionally, by optimizing the timing and image reconstruction, this method aims to maintain high-quality imaging, which is crucial for accurate diagnosis and monitoring of dementia. This advancement could lead to more frequent and safer imaging opportunities for patients, enhancing the ability to track disease progression with minimal risk.

What evidence suggests that this ultralow dose PET imaging technique is effective for dementia detection and monitoring?

Research has shown that both 18F-Florbetapir and 18F-Flutemetamol effectively detect Alzheimer's disease and other types of dementia. These substances highlight affected brain areas in PET scans. Studies have found that using these substances can boost doctors' confidence in diagnoses and aid in better patient care decisions. In this trial, participants will join an ultralow dose imaging group to assess image quality and optimize timing and reconstruction after reducing radiation doses by 10-100 fold. Early findings suggest that this method still provides clear images, promising safer and more comfortable scans. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's, mild cognitive impairment, other dementias, or healthy subjects interested in dementia research. Participants will undergo PET scans using a new technique aimed at reducing radiation exposure.

Inclusion Criteria

I am 18 years old or older.

Ability to provide informed consent and comply with study procedures

I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have a negative pregnancy test.

Exclusion Criteria

Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total)

Pregnant or breastfeeding individuals (negative pregnancy test required)

Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours to evaluate image quality and optimize timing and reconstruction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

12 months

Annual evaluation based on pooled images

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Florbetapir
• 18F-Flutemetamol

Trial Overview The study tests an ultralow dose PET imaging method using radioactive tracers (18F-Florbetapir or 18F-Flutemetamol) to detect and monitor various forms of dementia. It seeks to lower the radiation dose significantly compared to current standards.

How Is the Trial Designed?

Group I: ultralow dose imaging group Experimental Treatment 1 Intervention

Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Who Is Running the Clinical Trial?

Akiva Mintz

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07012993?term=AREA%5BBasicSearch%5D((18F)FLUTEMETAMOL)&rank=4

Ultralow Dose PET Imaging of 18F-Florbetapir ... This research study aims to evaluate an investigational ultralow dose PET imaging technique for Alzheimer's disease, mild cognitive impairment, other forms of ...

2. ejnmmiphys.springeropen.com ejnmmiphys.springeropen.com/articles/10.1186/s40658-024-00712-5

Ultra-fast [18F]florbetapir PET imaging using the uMI ... Ultra-fast [18F]florbetapir PET scans favor workflow efficiency, patient comfort, and potentiates for ultra-low dose scans. Data availability.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11683033/

Ultra-fast [18F]florbetapir PET imaging using the uMI ... List-mode PET data ... Ultra-fast [18F]florbetapir PET scans favor workflow efficiency, patient comfort, and potentiates for ultra-low dose scans.

4. withpower.com withpower.com/trial/phase-2-cognitive-dysfunction-4-2025-f3644

Ultralow Dose PET Imaging for Dementia This Phase 2 medical study run by Akiva Mintz is evaluating whether 18F-Florbetapir and 18F-Flutemetamol will have tolerable side effects & efficacy for ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/53/1/59/tab-figures-data

Effectiveness and Safety of 18 F-FDG PET in the Evaluation of ... For diagnosis of mixed AD and vascular dementia, 18F-FDG PET had sensitivity of 71% and specificity of 78%. For diagnosis of AD and mixed ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07012993?term=alzheimer

Ultralow Dose PET Imaging of 18F-Florbetapir ... 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.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf

Amyvid (Florbetapir F 18 Injection) for intravenous use Amyvid contains florbetapir F 18, a molecular imaging agent that binds to β-amyloid aggregates, and is intended for use with. PET imaging of the brain.

8. pi.lilly.com pi.lilly.com/us/amyvid-uspi.pdf

amyvid-uspi.pdf The time-activity curves for florbetapir F 18 in the brain of subjects with positive scans show continual signal increases from time zero through 30 minutes ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/53/1/59.short

Effectiveness and Safety of 18 F-FDG PET in the Evaluation of ... These data support the role of 18F-FDG PET as an effective and useful adjunct to other diagnostic information in the assessment of patients with ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8891344/

True ultra-low-dose amyloid PET/MRI enhanced with deep ... Eighteen participants underwent two separate 18F-florbetaben PET/MRI studies in which an ultra-low-dose (6.64 ± 3.57 MBq, 2.2 ± 1.3% of standard) or a standard- ...