[18F]MC225-PET in Neurodegenerative Disease

NCT05853471 | Unknown Phase 1 DMC

• 1 other identifier: 202100647
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PET; pharmacokinetic modeling; [18F]MC225

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Alzheimer's disease

ACTIVE COMPARATOR

Patients diagnosed with Alzheimer's disease

Drug: [18F]MC225

Mild Cognitive Impairment

ACTIVE COMPARATOR

Patients diagnosed with Mild Cognitive Impairment

Drug: [18F]MC225

Parkinson's disease

ACTIVE COMPARATOR

Patients diagnosed with Parkinson's disease

Drug: [18F]MC225

Interventions

[18F]MC225 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.

Alzheimer's disease; Mild Cognitive Impairment; Parkinson's disease

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is diagnosed with Alzheimer's disease, Parkinson's disease or Mild Cognitive Impairment

You may not qualify if:

• Use of any medication influencing the P-glycoprotein function
• History of neuropsychiatric disorders
• Contra-indications MRI
• Allergy contrast agent

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases; Alzheimer Disease; Parkinson Disease; Cognitive Dysfunction

Interventions

MC225 compound

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cognition Disorders

Study Officials

• Gert Luurtsema, Phd

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascalle Mossel, Msc

CONTACT

+31503616161; p.mossel@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: \[18F\]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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: May 10, 2023
• Study Start: February 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)