A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density
Primary Purpose
Healthy, Alzheimer Disease
Status
Completed
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
[11C]-UCB-J
Sponsored by
About this trial
This is an interventional other trial for Healthy
Eligibility Criteria
Inclusion Criteria:
Group 1
- 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 27.
Group 2
- 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.
Sites / Locations
- VU Medical Center, Dept. Radiology and Nuclear Medicine
- QPS Netherlands B.V.
- University Medical Center Groningen, Nuclear Medicine and Molecular Imaging
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy subjects [11C]-UCB-J
AD patients [11C]-UCB-J
Arm Description
Net dose of approximately 370 megabecquerel (MBq) of [11C]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
Net dose of approximately 370 megabecquerel (MBq) of [11C]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
Outcomes
Primary Outcome Measures
Measure [11C]-UCB-J plasma radioactivity levels in plasma over time
Measure concentration of radioactivity as a function of time according to pre-defined brain regions
Secondary Outcome Measures
Full Information
NCT ID
NCT03577262
First Posted
May 24, 2018
Last Updated
February 19, 2020
Sponsor
Alkermes, Inc.
Collaborators
QPS Netherlands B.V., University Medical Center Groningen, Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT03577262
Brief Title
A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
Collaborators
QPS Netherlands B.V., University Medical Center Groningen, Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
Adverse events will be recorded throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Alzheimer Disease
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
evaluate the kinetics and test-retest repeatability and reproducibility of the radioligand [11C]-UCB-J for imaging synaptic density in up to10 healthy subjects and then mild to moderate Alzheimer's Disease patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects [11C]-UCB-J
Arm Type
Experimental
Arm Description
Net dose of approximately 370 megabecquerel (MBq) of [11C]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
Arm Title
AD patients [11C]-UCB-J
Arm Type
Experimental
Arm Description
Net dose of approximately 370 megabecquerel (MBq) of [11C]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
Intervention Type
Other
Intervention Name(s)
[11C]-UCB-J
Intervention Description
IV radioligand given prior to and during positron emission tomography (PET) scan
Primary Outcome Measure Information:
Title
Measure [11C]-UCB-J plasma radioactivity levels in plasma over time
Time Frame
Day 1 to 28
Title
Measure concentration of radioactivity as a function of time according to pre-defined brain regions
Time Frame
Day 1 to 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Group 1
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 27.
Group 2
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coordinating PI
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU Medical Center, Dept. Radiology and Nuclear Medicine
City
Amsterdam
Country
Netherlands
Facility Name
QPS Netherlands B.V.
City
Groningen
Country
Netherlands
Facility Name
University Medical Center Groningen, Nuclear Medicine and Molecular Imaging
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density
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