[18F]MC225-PET in Neurodegenerative Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

P-glycoprotein Function in Brain Diseases

NCT00677885

Alzheimer Disease Parkinson Disease Frontotemporal Lobar Degeneration

COMPLETED

PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand

NCT03958630

Dementia

TERMINATED PHASE1

A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions

NCT00870974

Parkinson Disease Huntington Disease Autistic Spectrum Disorders +3 more

COMPLETED PHASE1

Safety and Efficacy of Positron Emission Tomography (PET) Imaging With MNI-558

NCT01217021

Alzheimer Disease

COMPLETED EARLY_PHASE1

Molecular Cerebral Imaging in Incipient Dementia (MCI-ID) II

NCT02317250

Mild Cognitive Impairment

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurodegenerative Diseases Alzheimer Disease Parkinson Disease Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

\[18F\]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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alzheimer's disease

Patients diagnosed with Alzheimer's disease

Group Type ACTIVE_COMPARATOR

[18F]MC225

Intervention Type DRUG

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.

Mild Cognitive Impairment

Patients diagnosed with Mild Cognitive Impairment

Group Type ACTIVE_COMPARATOR

[18F]MC225

Intervention Type DRUG

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.

Parkinson's disease

Patients diagnosed with Parkinson's disease

Group Type ACTIVE_COMPARATOR

[18F]MC225

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No