[18F]MC225-PET in Neurodegenerative Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853471
• Other study ID #: 202100647
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: Pascalle Mossel, Msc
• Phone: +31503616161
• Email: p.mossel[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Neurodegenerative Diseases
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P-glycoprotein function	The function of P-glycoprotein at the blood-brain barrier measured by PET tracer-uptake (volume of distribution) in the brain	60 minutes