Neuro-Degenerative Disease Clinical Trial
Official title:
Characterizing the Safety of [Carbon-11]Butanol and Estimating the Test-Retest Variance in Measurements of Its Whole Body Biokinetics Under Zero-Biological-Change Conditions
This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and clinical laboratory tests of intrernal organ function will be acquired before and at several timepoints after administration of the radiopharmaceutical. Radiation exposures will be estimated with the MIRD Formalism.
Vital signs (VSs) will be measured, electrocardiograms (ECGs) will be acquired, and blood will be sent to the clinical laboratory for safety assessments before a single dose, intravenous (IV) administration of 555 MBq of Carbon-11 butanol. VSs will be re-measured, ECGs will be acquired again, and more blood will be sent to the clinical laboratory for repeat safety assessments after 2 hours of whole body (WB) scanning. WB scanning will consist of imaging acquisition sweeps of 200 cm from head-to-toe over 180 secs (3 min). Up to 40 sweeps per imaging session will be performed. The subjects will then be given a rest period ("coffee break") for about two hours, after which the entire sequence of events will be repeated. The primary outcome measure will be related to radiation safety derived from the areas under the time-activity curves (AUCs) for internal organs. Co-primary clinical safety measures will include changes in VSs, ECG parameters such as the PR and corrected QT intervals, and clinical laboratory tests, such as proteins that reflect renal and hepatic function. Secondary endpoints will include the time-activity curves (TACs) and total volumes of distribution (VT) in several brain regions. The results should allow calculation of the repeatability coefficients (RCs) under zero-biological-change conditions. RC values will be essential for understanding whether future measurements of effect sizes in response to therapeutic maneuvers or the differences between groups are meaningful. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05586750 -
Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
|
Phase 4 | |
Recruiting |
NCT04863859 -
Persons With Dementia and Their Extended Family Caregivers
|
||
Recruiting |
NCT05655650 -
Identifying Biomarkers in Alzheimer's Disease
|
||
Completed |
NCT04937127 -
Efficiency of E-learning and Role-playing for the Training of Nursing Home Caregivers in the Support of Agitation in Neurodegenerative Diseases
|
||
Enrolling by invitation |
NCT03197363 -
BiaĆystok PLUS - Polish Longitudinal University Study
|
||
Enrolling by invitation |
NCT03322306 -
Establishment of Genetic Basis for Neurological Disease by Genetic Screening
|
||
Completed |
NCT03439163 -
Large Sample PD Patients and Healthy Controls
|
N/A | |
Withdrawn |
NCT05921929 -
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
|
Phase 1 | |
Recruiting |
NCT05209698 -
Self-Management Behaviors of Arabs and Jews With Parkinson's Disease and Their Associations With Health Outcomes
|
||
Completed |
NCT04362228 -
The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
|
N/A | |
Enrolling by invitation |
NCT05008094 -
The Epidemiology of Parkinson's Disease in Croatia and the Influence of Genetic Factors and Microbiota on the Progression and Treatment Outcomes of the Disease (GiOPARK)
|
||
Completed |
NCT03279991 -
Neuromed- Integrated Health Life Platform and Biobank
|
||
Active, not recruiting |
NCT04228653 -
Long-Term Follow-up Safety After DDS Implantation With/Without CDNF Infusions
|
Phase 1/Phase 2 | |
Recruiting |
NCT05328492 -
Volume Mode Non-invasive Ventilation in Amyotrophic Lateral Sclerosis
|
N/A | |
Not yet recruiting |
NCT06151600 -
A Prospective Natural History and Outcome Measure Discovery Study of Charcot-Marie-Tooth Disease, Type 4J
|
||
Recruiting |
NCT04880356 -
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
|
||
Active, not recruiting |
NCT03609125 -
Cord Blood Serum in the Treatment of Neuro-Degenerative Ophthalmic Diseases. 1-Glaucoma
|
N/A | |
Recruiting |
NCT03153670 -
3T MRI in Patients With Deep Brain Stimulation (DBS)
|
N/A | |
Completed |
NCT03775538 -
Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study
|
Phase 1/Phase 2 | |
Enrolling by invitation |
NCT04635540 -
Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease
|
N/A |