[18F]MC225-PET in Neurodegenerative Disease

University Medical Center Groningen (UMCG)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Neurodegenerative Diseases; Parkinson Disease

Treatments: Drug: [18F]MC225

Study type: Interventional

Funder types: Other

Identifiers

NCT05853471

202100647

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Alzheimer's disease

Active Comparator group

Description:

Patients diagnosed with Alzheimer's disease

Treatment:

Drug: [18F]MC225

Mild Cognitive Impairment

Active Comparator group

Description:

Patients diagnosed with Mild Cognitive Impairment

Treatment:

Drug: [18F]MC225

Parkinson's disease

Active Comparator group

Description:

Patients diagnosed with Parkinson's disease

Treatment:

Drug: [18F]MC225