[18F]APN-1607 PET Imaging for Alzheimer's Disease

Not currently recruiting at 3 trial locations

Overseen By Brad Navia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: APRINOIA Therapeutics, LLC

Must be taking: AD symptomatic treatment

Must not be taking: Investigational drugs, Cognitive drugs

Disqualifiers: Alcohol, Drug abuse, Cancer, 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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a new imaging agent, [18F]APN-1607, is absorbed in the brains of individuals with Alzheimer's disease, mild cognitive impairment, and those without memory problems. PET scans, which are special imaging tests, observe how the agent behaves in different groups. This can help researchers better understand Alzheimer's and potentially improve diagnosis. Individuals experiencing memory issues or Alzheimer's symptoms, as well as healthy individuals without memory problems, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that any medications taken for Alzheimer's disease must be stable for at least 30 days before screening and throughout the study. If you are on such medications, you should not change them during the trial.

Is there any evidence suggesting that [18F]APN-1607 is likely to be safe for humans?

Research has shown that [18F]APN-1607 is generally safe for people. It is used in PET scans to help doctors detect tau protein build-up in the brains of Alzheimer's patients. So far, no major reports of serious side effects have emerged from using [18F]APN-1607 for these scans, suggesting its safety in these studies.

The treatment is now in phase 2 trials, indicating it has already passed initial safety tests. The current focus is more on its effectiveness rather than just safety. While no treatment is completely without risk, [18F]APN-1607 demonstrated a promising safety record in earlier research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Alzheimer's disease focus on managing symptoms or slowing disease progression with medications like cholinesterase inhibitors or NMDA receptor antagonists. However, [18F]APN-1607 is unique because it uses a novel PET imaging agent to help visualize tau protein deposits in the brain, which are a hallmark of Alzheimer's disease. This imaging technique could provide a clearer and more direct way to assess the presence and progression of tau pathology, potentially leading to earlier and more accurate diagnoses. Researchers are excited about [18F]APN-1607 because it offers a new way to see inside the brain and understand Alzheimer's better, which could pave the way for improved treatment strategies in the future.

What evidence suggests that [18F]APN-1607 PET imaging is effective for Alzheimer's Disease?

Research has shown that [18F]APN-1607 PET imaging, which participants in this trial will undergo, holds promise for Alzheimer's disease. Studies indicate it helps visualize tau protein buildup in the brains of people with Alzheimer's. This buildup is linked to brain changes and memory problems. The imaging technique effectively detects tau deposits, often present in Alzheimer's patients. By highlighting these deposits, it could help doctors better understand disease progression. Overall, it offers a useful way to observe brain activity. ^{1 2 6 7 8}

Who Is on the Research Team?

David Russell, M.D., Ph.D

Principal Investigator

Invicro

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-85, who are either not able to have children or agree to use contraception. It's for those with mild to moderate Alzheimer's Disease (MDAD), AD dementia, or healthy without cognitive impairment. Participants must be in good physical health with no relevant medical issues.

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed.

Has a clinical dementia rating (CDR) score of 0.

I am a woman who cannot become pregnant or will not be pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo PET imaging using [18F]APN-1607 to assess uptake patterns

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• [18F]APN-1607

Trial Overview [18F]APN-1607 uptake patterns are being compared across individuals with MDAD, AD dementia, and healthy subjects. The goal is to see how this imaging agent behaves differently among these groups which could help in understanding and diagnosing Alzheimer's Disease.

How Is the Trial Designed?

Group I: [18F]APN-1607 Experimental Treatment 1 Intervention

Subjects will undergo PET imaging using \[18F\]APN-1607.

Who Is Running the Clinical Trial?

APRINOIA Therapeutics, LLC

Lead Sponsor

Trials

2

Recruited

170+

Aprinoia Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

130+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8868571/

18F-APN-1607 Tau Positron Emission Tomography ... This study showed that 18F-APN-1607 PET imaging could help to clarify the spatial distribution of tau deposition in AD patients and presented a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35221982/

18F-APN-1607 Tau Positron Emission Tomography ... 18 F-APN-1607 PET may serve as an effective imaging marker for visualizing the change pattern of tau protein deposition in AD patients, ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2020.00604/full

Associations of [ 18 F]-APN-1607 Tau PET Binding in ... Our results suggested that [ 18 F]-APN-1607 PET sensitively detected tau deposition in AD and that individual tauopathy correlated with impaired cerebral ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589004223015031

Article Improved interpretation of 18 F-florzolotau PET in ... We developed a normalization-free deep-learning (NFDL) model for 18 F-florzolotau PET, which achieved significantly higher accuracy for both PSP and MSA-P.

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1148054/full

Visual reading for [18F]Florzolotau ([18F]APN-1607) tau ... In conclusion, our study shows that the proposed visual scale of [18F]Florzolotau ([18F]APN1607) tau-PET is strongly associated with SUVr quantification and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05043675

Clinical Evaluation of [18F]APN-1607 PET Uptake in ... To expand the safety and tolerability profile for the administration of [18F]APN-1607 and PET scanning. · To assess regional patterns of [18F]APN-1607 uptake.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37250400/

Visual reading for [18F]Florzolotau ([18F]APN-1607) tau ... The visual reading method generated a visual score of [ 18 F]Florzolotau tau-PET with good sensitivity and specificity to identify AD-D or ...

8. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2021.598234/full

Parametric Estimation of Reference Signal Intensity for ... [18F]-APN-1607 ([18F]-PM-PBB3) PET imaging data were for Cohort II, which included 21 patients with a clinical diagnosis of amyloid PET-positive ...