Primary objective:* Assess the test-retest repeatability and reproducibility of radioligand [11C]-UCB-J binding.Secondary objective:* Compare the precision and accuracy of PET data analysis using 60 versus 90 minutes of scan data.* Assess group…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Alzheimer's Disease
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
[11C]-UCB-J Kinetics Parameters
PET Parameters
Safety and Tolerability Parameters
Secondary outcome
Biomarker Parameters
Background summary
This study is designed to quantify reproducibility of [11C]-UCB-J over a
therapeutically relevant 28-day period and inform potential utilization of this
tracer in future interventional studies.
Study objective
Primary objective:
* Assess the test-retest repeatability and reproducibility of radioligand
[11C]-UCB-J binding.
Secondary objective:
* Compare the precision and accuracy of PET data analysis using 60 versus 90
minutes of scan data.
* Assess group differences in [11C]-UCB-J binding in pre-defined brain regions
at each assessment time point.
Exploratory objective:
* Assess plasma-derived central nervous system (CNS) biomarkers.
Study design
After assessing eligibility during a 4-week screening period, approximately 20
subjects will participate in the PET acquisition phase of the study. Drop-outs
or unevaluable subjects may be replaced for a target sample size of 20
completed and evaluable subjects.
PET scanning duration will be initially set to 90 minutes. After a minimum of 4
subjects have completed baseline and Day 28 scans, 90 minute and 60 minute scan
data will be analyzed. Based on this analysis, and at the discretion of the
investigator, it will be decided whether the remaining subjects will require 60
or 90 minute scans.
Intervention
Injection with [11C]-UCB-J .
Study burden and risks
This study is being conducted in healthy volunteers and mild-to-moderate
Alzeheimer diseased volunteers. There are no anticipated benefitis or risks of
the ligand [11C]-UCB-J. Please see the IMPD for futher information.
Technology Square 300
Cambridge MA 02139
US
Technology Square 300
Cambridge MA 02139
US
Listed location countries
Age
Inclusion criteria
Group 1:
Healthy male or female age 50 * 80 years old, inclusive, at the time of informed consent.;Group 2:
Adult males or females age 50 * 80 years old, inclusive, at the time of informed consent.
Confirmed diagnosis of mild-to-moderate AD.
Exclusion criteria
History or current evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD in Group 2), psychiatric, renal, or other major disease, as determined by the Investigator.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-001503-37-NL |
| CCMO | NL65992.056.18 |
| Other | see J |