Clinical trial NCT05853471: [18F]MC225-PET in Neurodegenerative Disease
Official title: Evaluation of [18F]MC225-PET to Measure P-glycoprotein Function in Neurodegenerative Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neurodegenerative Diseases
Alzheimer Disease
Parkinson Disease
Mild Cognitive Impairment
Keywords: PET
pharmacokinetic modeling
[18F]MC225
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: P-glycoprotein function
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Gert Luurtsema, Phd
role: PRINCIPAL_INVESTIGATOR
References: