A Non-therapeutic Feasibility Study to Evaluate the Kinetics and Test-retest Repeatability and Reproducibility of the Radioligand [11C]-UCB-J for Imaging Synaptic Density in Healthy Subjects and Mild-to-moderate Alzheimer's Disease Subjects
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- Measure concentration of radioactivity as a function of time according to pre-defined brain regions
Study Overview
Brief Summary
Up to 20 subjects will receive an injection with [11C]-UCB-J followed by a PET scan on Days 1 and 28
Detailed Description
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 will be replaced for a target sample size of 20 completed and evaluable subjects.
During the screening period, a 3D T1-weighted MRI must be acquired and reviewed for exclusion criteria and acquisition quality.
On the day of radioligand administration (Day 1), subjects will come to the study center for an ambulatory visit (Visit 1). After re-confirming eligibility, all subjects will receive an injection with [11C]-UCB-J followed by a PET scan.
Using an arterial line and manual sampling, blood samples will be collected up to 90 minutes after radioligand injection in order to quantify radioactivity concentration in whole blood and plasma as well as parent fraction over time.
Subjects will return to the clinic for one more ambulatory visit on Day 28 ± 3 (Visit 2). The same procedures will be performed as on Day 1.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or female age 55 - 75 years old, inclusive, at the time of informed consent.
- •Mini-mental state examination (MMSE) greater than or equal to
- •Adult males or females age 55 - 75 years old, inclusive, at the time of informed consent.
- •Confirmed diagnosis of mild-to-moderate AD, defined as:
- •National Institute on Aging - Alzheimer's Association (NIA-AA) "probable" diagnosis (see Appendix 2);
- •MMSE 18-26.
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.
Outcomes
Primary Outcomes
Measure concentration of radioactivity as a function of time according to pre-defined brain regions
Time Frame: Day 1 to 28
Measure [11C]-UCB-J plasma radioactivity levels in plasma over time
Time Frame: Day 1 to 28
Secondary Outcomes
No secondary outcomes reported