[18F]MC225-PET in Neurodegenerative Disease

Sponsor

University Medical Center Groningen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05853471

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

P-glycoprotein, an efflux transporter at the blood-brain barrier plays an important role in de development of neurodegenerative disease. A novel PET tracer ([18F]MC225) was developed to measure the function of P-glycoprotein and was tested with succes in healthy volunteers. This study aims to evaluate [18F]MC225 in neurodegenerative disease.

Condition or Disease	Intervention/Treatment	Phase
Neurodegenerative Diseases Alzheimer Disease Parkinson Disease Mild Cognitive Impairment	Drug: [18F]MC225	Phase 1/Phase 2

Detailed Description

A decrease in P-glycoprotein (P-gp) function is associated with the onset of neurodegenerative disease. New treatment strategies in neurodegenerative disease, including Parkinson's disease and Alzheimer's disease, aim to restore the P-gp function. To evaluate the effect of these potential therapies, measurement of the P-gp function is necessary. Up until now [11C]verapamil is considered to be the gold standard to measure P-gp function. However tracer uptake in the brain of [11C]verapamil is too low for adequate measurement of treatment effect, especially of restoring P-gp function. A novel PET tracer to measure P-gp function, [18F]MC225, has the potential advantage of higher brain uptake values at baseline and might therefore able to measure both up- and down regulation P-gp function. [18F]MC225 was recently studied in healthy volunteers and a method to quantify P-gp function was developed. This study aims to evaluate [18F]MC225 to measure P-gp function in neurodegenerative disease.

To this aim 10 MCI patients, 10 patients with Alzheimer's disease and 10 Parkinson's disease patients will be included and undergo one 60 min dynamic [18F]MC225 PET scan, combined with a 10 min [15O]H2O PET. Tracer uptake values (Vt) and influx (K1) in several brain regions of interest, representing local P-gp function will be compared with the [18F]MC225 uptake values in the brain of healthy volunteers obtained in a previous study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

[18F]MC225 is administrated to patients in three groups to evaluate the P-glycoprotein function in these groups and compare the results with the P-gp function of healthy volunteers obtained in a previous study[18F]MC225 is administrated to patients in three groups to evaluate the P-glycoprotein function in these groups and compare the results with the P-gp function of healthy volunteers obtained in a previous study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of [18F]MC225-PET to Measure P-glycoprotein Function in Neurodegenerative Disease

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alzheimer's disease Patients diagnosed with Alzheimer's disease	Drug: [18F]MC225 All participants will undergo a PET scan with [18F]MC225. No pharmaceutical effects are expected and the study will exclusively have a diagnostic purpose. However, since [18F]MC225 is a new PET tracer, it is included in pharmaceutical studies and any study performed with [18F]MC225 will be automatically be registered as intervention study.
Active Comparator: Mild Cognitive Impairment Patients diagnosed with Mild Cognitive Impairment	Drug: [18F]MC225 All participants will undergo a PET scan with [18F]MC225. No pharmaceutical effects are expected and the study will exclusively have a diagnostic purpose. However, since [18F]MC225 is a new PET tracer, it is included in pharmaceutical studies and any study performed with [18F]MC225 will be automatically be registered as intervention study.
Active Comparator: Parkinson's disease Patients diagnosed with Parkinson's disease	Drug: [18F]MC225 All participants will undergo a PET scan with [18F]MC225. No pharmaceutical effects are expected and the study will exclusively have a diagnostic purpose. However, since [18F]MC225 is a new PET tracer, it is included in pharmaceutical studies and any study performed with [18F]MC225 will be automatically be registered as intervention study.

Arm

Intervention/Treatment

Active Comparator: Alzheimer's disease

Patients diagnosed with Alzheimer's disease

Drug: [18F]MC225

All participants will undergo a PET scan with [18F]MC225. No pharmaceutical effects are expected and the study will exclusively have a diagnostic purpose. However, since [18F]MC225 is a new PET tracer, it is included in pharmaceutical studies and any study performed with [18F]MC225 will be automatically be registered as intervention study.

Active Comparator: Mild Cognitive Impairment

Patients diagnosed with Mild Cognitive Impairment

Drug: [18F]MC225

Active Comparator: Parkinson's disease

Patients diagnosed with Parkinson's disease

Drug: [18F]MC225

Outcome Measures

Primary Outcome Measures

P-glycoprotein function [60 minutes]
The function of P-glycoprotein at the blood-brain barrier measured by PET tracer-uptake (volume of distribution) in the brain

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is diagnosed with Alzheimer's disease, Parkinson's disease or Mild Cognitive Impairment

Exclusion Criteria:

Use of any medication influencing the P-glycoprotein function
History of neuropsychiatric disorders
Contra-indications MRI
Allergy contrast agent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713GZ

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Principal Investigator: Gert Luurtsema, Phd, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gert Luurtsema, Principal Investigator, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05853471

Other Study ID Numbers:

202100647

First Posted:

May 10, 2023

Last Update Posted:

May 10, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gert Luurtsema, Principal Investigator, University Medical Center Groningen

PET

pharmacokinetic modeling

[18F]MC225

Additional relevant MeSH terms:

Parkinson Disease

Alzheimer Disease

Neurodegenerative Diseases

Cognitive Dysfunction

Study Results

No Results Posted as of May 10, 2023