A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density

• ClinicalTrials.gov Identifier: NCT03577262
• Recruitment Status: Completed
• First Posted: July 5, 2018
• Last Update Posted: February 20, 2020
• Sponsor: Alkermes, Inc.
• Collaborators: QPS Netherlands B.V.; University Medical Center Groningen; VU University Medical Center
• Information provided by (Responsible Party): Alkermes, Inc.

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

Condition or disease	Intervention/treatment	Phase
Healthy; Alzheimer Disease	Other: [11C]-UCB-J	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Other
• 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
• Actual Study Start Date: July 23, 2018
• Actual Primary Completion Date: August 2, 2019
• Actual Study Completion Date: August 2, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Healthy subjects [11C]-UCB-J; 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	Other: [11C]-UCB-J; IV radioligand given prior to and during positron emission tomography (PET) scan
Experimental: AD patients [11C]-UCB-J; 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	Other: [11C]-UCB-J; IV radioligand given prior to and during positron emission tomography (PET) scan

Outcome Measures

Primary Outcome Measures :

1. Measure [11C]-UCB-J plasma radioactivity levels in plasma over time [ Time Frame: Day 1 to 28 ]
2. Measure concentration of radioactivity as a function of time according to pre-defined brain regions [ Time Frame: Day 1 to 28 ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

  1. National Institute on Aging - Alzheimer's Association (NIA-AA) "probable" diagnosis (see Appendix 2);
  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.

Contacts and Locations

Locations

Netherlands

VU Medical Center, Dept. Radiology and Nuclear Medicine

Amsterdam, Netherlands

QPS Netherlands B.V.

Groningen, Netherlands

University Medical Center Groningen, Nuclear Medicine and Molecular Imaging

Groningen, Netherlands

Sponsors and Collaborators

Alkermes, Inc.

QPS Netherlands B.V.

University Medical Center Groningen

VU University Medical Center

Investigators

• Principal Investigator: Coordinating PI; University Medical Center Groningen

More Information

• Responsible Party: Alkermes, Inc.
• ClinicalTrials.gov Identifier: NCT03577262
• Other Study ID Numbers: RDN-NI-001
• First Posted: July 5, 2018
• Last Update Posted: February 20, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders