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

NCT ID: NCT03577262

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-08-02

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.

Conditions

Healthy; Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

[11C]-UCB-J

Intervention Type: OTHER

IV radioligand given prior to and during positron emission tomography (PET) scan

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

Group Type: EXPERIMENTAL

[11C]-UCB-J

Intervention Type: OTHER

IV radioligand given prior to and during positron emission tomography (PET) scan

Interventions

[11C]-UCB-J

IV radioligand given prior to and during positron emission tomography (PET) scan

Intervention Type: OTHER

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:

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

QPS Netherlands B.V.

INDUSTRY

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Alkermes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coordinating PI

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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

Countries

Netherlands

Other Identifiers

RDN-NI-001

Identifier Type: -

Identifier Source: org_study_id