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

NCT03577262 | Completed Early Phase 1

• 1 other identifier: RDN-NI-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

Up to 20 subjects will receive an injection with \[11C\]-UCB-J followed by a PET scan on Days 1 and 28

Conditions

Healthy; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Measure [11C]-UCB-J plasma radioactivity levels in plasma over time

  Day 1 to 28

• Measure concentration of radioactivity as a function of time according to pre-defined brain regions

  Day 1 to 28

Study Arms (2)

Healthy subjects [11C]-UCB-J

EXPERIMENTAL

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

AD patients [11C]-UCB-J

EXPERIMENTAL

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

Interventions

[11C]-UCB-J OTHER

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

AD patients [11C]-UCB-J; Healthy subjects [11C]-UCB-J

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alkermes, Inc.: lead
• QPS Netherlands B.V.: collaborator
• University Medical Center Groningen: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (3)

VU Medical Center, Dept. Radiology and Nuclear Medicine

Amsterdam, Netherlands

Location

QPS Netherlands B.V.

Groningen, Netherlands

Location

University Medical Center Groningen, Nuclear Medicine and Molecular Imaging

Groningen, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

1-((3-(methylpyridin-4-yl)methyl)-4-(3,4,5-trifluorophenyl)pyrrolidin-2-one

Condition Hierarchy (Ancestors)

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

Study Officials

• Coordinating PI

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 5, 2018
• Study Start: July 23, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)