Topography Staging and Dual Phase Image Quantification of Tau PET in Cognitive Impairment Subjects (NCT04169126) | Clinical Trial Compass
UnknownPhase 2
Topography Staging and Dual Phase Image Quantification of Tau PET in Cognitive Impairment Subjects
Taiwan300 participantsStarted 2019-04-01
Plain-language summary
A second-generation tau PET image tracer 18F-PM-PBB3 (APN-1607 or MNI-958) has been developed by National Institute of Radiological Sciences. The new tracer solved the off-target binding issue. This study will evaluate new quantitative methods with PMPBB3, by utilized dual phase scanning protocol to extract blood flow and Tau protein binding information, to evaluate appropriate reference brain regions, to improve the normalization efficiency of brain imaging, and to establish a brain template image analysis platform.
Who can participate
Age range55 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓.1 All subjects
✓. Age between 55-80 years
✓. Written informed consent must be obtained before any assessment is performed.
✓. Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
✓. Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
✓. Male subjects must not donate sperm for the study duration.
✓. Willing to undergo repeated MRIs and at least two PET scans.
✓.2 Patient with Prodromal AD or AD dementia
Exclusion criteria
✕. Already receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation that include but not limited to Parkinsonism, Parkinson's disease dementia, schizophrenia, major depression, epilepsy, alcohol or drug abuse, major head trauma with consciousness loss
✕. Severe progressive or unstable systemic disease that may interfere with the follow-up and test results. These included but not limited to cancer in the past 5 years, end stage renal or liver dysfunction, clinical significant myocardial infarction (New York Heart Association Functional Classification III-IV), Active disease that received admission in the past one year and unstable angina. Other diseases that were not listed but may interfere with the follow-up or test will be judged by the principle investigator.
What they're measuring
1
Tau Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan.
✕. Any treatment that suggests any of the aforementioned disease will be excluded.
✕. Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
✕. Contraindications or previously failure for receiving brain magnetic resonance imaging or PET scan.
✕. History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval.
✕. Have an ECG obtained prior to the 18F-PM-PBB3 PET scan that in the opinion of the investigator is clinically significant regarding the subject's participation in the study.