[18F]MC225-PET in Neurodegenerative Disease

Phase 1

Recruiting

• Conditions: Neurodegenerative Diseases; Parkinson Disease; Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Drug: [18F]MC225

• Registration Number: NCT05853471
• Lead Sponsor: University Medical Center Groningen

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.

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 Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-11-09
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson's disease	[18F]MC225	Patients diagnosed with Parkinson's disease
Mild Cognitive Impairment	[18F]MC225	Patients diagnosed with Mild Cognitive Impairment
Alzheimer's disease	[18F]MC225	Patients diagnosed with Alzheimer's disease

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands