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

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ClinicalTrials.gov Identifier: NCT03577262
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
QPS Netherlands B.V.
University Medical Center Groningen
VU University Medical Center
Information provided by (Responsible Party):
Rodin Therapeutics

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


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




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577262


Contacts
Contact: Floor Morrien 31 50 304 8000 floor.morrien@qps.com

Locations
Netherlands
VU Medical Center, Dept. Radiology and Nuclear Medicine Recruiting
Amsterdam, Netherlands
Contact: Prinicipal Investigator         
QPS Netherlands B.V. Recruiting
Groningen, Netherlands
Contact: Principal Investigator         
University Medical Center Groningen, Nuclear Medicine and Molecular Imaging Not yet recruiting
Groningen, Netherlands
Contact: Prinicipal Investigator         
Sponsors and Collaborators
Rodin Therapeutics
QPS Netherlands B.V.
University Medical Center Groningen
VU University Medical Center
Investigators
Principal Investigator: Coordinating PI University Medical Center Groningen

Responsible Party: Rodin Therapeutics
ClinicalTrials.gov Identifier: NCT03577262     History of Changes
Other Study ID Numbers: RDN-NI-001
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
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