NCT07348250LeállítvaKorai 1. fázis
Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson's Disease
An Open-label Study to Evaluate Brain α-Synuclein Deposition Using Positron Emission Tomography (PET) and [18F]MK-0947 in Patients With Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 27.
Megadott ok: Study terminated due to site closure.
Rövid összefoglaló (regiszter, angolul)
This clinical study is being conducted to learn more about a new imaging drug called [18F]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders. The main goal of this study is to find out if [18F]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time. Who can join? Adults who have PD or who are healthy 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 two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants. Why is this important? There is currently no cure for PD, 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 PD and similar conditions in the future.
- Állapot (regiszter)
- Leállítva
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 16 (tényleges)
- Első benyújtás
- 2025. dec. 29.
- Kezdés
- 2025. dec. 8.
- Elsődleges befejezés
- 2026. márc. 26.
- Fő szponzor
- Invicro
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07348250
Ki nem vehet részt
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Korábbi kezelés
- Contraindication to PET or MRI procedures (e.g., implants, claustrophobia)
- Current or prior participation in investigational drug study within 30 days
Más betegség
- Clinically significant hepatic, renal, cardiovascular, pulmonary, or systemic illness
- History of severe allergic reactions to PET tracers or related compounds
- Any condition that may interfere with study conduct or participant safety
Egyéb
- Unwilling or unable to provide informed consent
- Pregnant or breastfeeding
Kiket keres a vizsgálat
- Signed informed consent prior to any study procedures
- Women of childbearing potential: abstinent or use 2 contraception methods (one barrier) during study and 90 days post last injection
- Men: use 2 contraception methods and refrain from sperm donation during study and 90 days post last injection
- PD \& HE participants: Age 40-80 years; HP participants: Age 18-50 years
- Adequate circulation and normal clotting for arterial cannulation (if applicable)
- HE participants: no neurological disorder, no first-degree relative with idiopathic PD
- HP participants: healthy with no clinically relevant findings
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Invicro (dba Perceptive) | New Haven | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.