Actively Recruiting
First-in-Human Study for the Safety and Evaluation of Two 4R Tau Ligands as Potential PET Radioligands for Imaging Tau Protein in the Brain
Led by Invicro · Updated on 2026-01-16
24
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
I
Invicro
Lead Sponsor
E
Enigma Biomedical USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study is being conducted to learn more about two new imaging drugs, called \[18F\]ABBV-964i and \[18F\]ABBV-965i, which are designed to help doctors see changes in the brain related to a condition called Progressive Supranuclear Palsy (PSP). PSP is a rare disease that affects movement, balance, and thinking. These drugs are used with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called tau builds up. Tau buildup is linked to PSP and other brain diseases. The main goal of this study is to find out if these imaging drugs are safe for people and if they work well to show tau in the brain. The study will also look at how the drugs move through the body and how much radiation they give off. Researchers hope this information will help develop better tools for diagnosing PSP and tracking how it changes over time. Who can join? Adults who are healthy or who have PSP may be able to take part. Participants will have screening tests to make sure they qualify. What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into three parts: Part A checks radiation levels in healthy volunteers, Part B looks at how the drugs work in the brain of PSP patients and healthy volunteers, and Part C (optional) repeats scans to see if results are consistent. Why is this important? There is currently no cure for PSP, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PSP and similar conditions in the future.
CONDITIONS
Official Title
First-in-Human Study for the Safety and Evaluation of Two 4R Tau Ligands as Potential PET Radioligands for Imaging Tau Protein in the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 to 80 years for PSP participants
- Male or female aged 18 to 80 years for healthy volunteers
- Body weight between 43 and 120 kg (95 to 265 lb)
- Women of childbearing potential must use two forms of contraception (one barrier method) during the study and for 30 days after last injection or remain abstinent
- Men must use two forms of contraception and avoid sperm donation during the study and for 90 days after last injection
- Adequate circulation and normal blood clotting for arterial cannulation
- Ability to move sufficiently and lie still during imaging
- Healthy volunteers must have no clinically relevant findings or cognitive impairment and provide informed consent
- PSP participants must have a clinical diagnosis per NINDS-SPSP criteria, MRI consistent with PSP, ability to walk, tolerate MRI, comply with study procedures, and have a caregiver available if needed
- Provide informed consent or assent with legally authorized representative consent if applicable
You will not qualify if you...
- History of drug or alcohol abuse in the past 12 months
- Clinically significant laboratory abnormalities or unstable illness
- Use of investigational drugs or devices within 30 days prior to study
- Pregnant, lactating, or breastfeeding women
- Significant gastrointestinal, cardiovascular, hepatic, renal, or other major medical conditions
- Abnormal blood clotting parameters if arterial sampling is required
- MRI contraindications such as implants or claustrophobia for PSP participants
- Use of over-the-counter medications or supplements within 2 weeks prior for healthy volunteers
- Use of anti-hemostasis medications within 2 weeks prior to arterial line placement for PSP participants
- Inability to lie still for approximately 90 minutes
- Major surgery or significant blood loss within 4 weeks prior to study
- Positive test for Hepatitis B, Hepatitis C, or HIV
- Deemed unsuitable for participation by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Invicro (dba Perceptive)
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
D
David Russell, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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