Evaluation of a novel PET tracer [18F]MC225 to measure the function of P-glycoprotein, a transporter at the blood brain barrier, in neurodegenerative disease

Phase 1

• Conditions: - Alzheimer's disease - Mild Cognitive Impairment - Parkinson's disease; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2021-005024-37-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-19
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Alzheimer's disease
- Patients who meet the criteria for Alzheimer’s disease and are mentally competent to give informed consent:
I. Documented cognitive decline
II. Progressive course of cognitive decline
III.Complaints in the following areas
a. memory
b. language
c. visuospatial functions
d. executive functions
IV. Absence of cerebrovascular disease or signs of other neurodegenerative disease except for Alzheimer’s disease.

and show biomarkers positive for AD:
I. amyloid-depositions in the brain showed by low Aß42 in CSF and/or positive amyloid imaging at a PIB-PET
II. Neuronal damages showed by increased tau/ptau in CSF or;
decreased FDG uptake at the parietotemporal lobe or;
disproportional atrophy of the medial, basal and lateral temporallobes, generalised atrophy and/or biparietal atrophy.
The diagnosis Alzheimer’s disease is made by a multidisciplinary team consisting of neurologists, psychologists and internists.

2. Mild Cognitive Impairment
Patient is not meeting the criteria for Alzheimers disease, but shows:
- Decline in one or more cognitive domains (showed by a neuropsychological examination)
- No interference of symptoms with daily life
The diagnosis Alzheimer’s disease is made by a multidisciplinary team consisting of psychiatrists, neurologists, psychologists and internists.
- Absence of cerebrovascular disease or signs of other neurodegenerative disease except for MCI
The diagnosis MCI is made by a multidisciplinary team consisting of neurologists, psychologists and internists

3. Parkinson's disease
Symptoms of bradykinesia and one of the following symptoms (25):
- rigidity
- rest tremor
- instability (not related to visual, cerebellar or proprioceptive disorders)
- no other explanation for abovementioned symptoms at MRI
- The diagnosis Parkinson’s disease is made by a neurologist
- Absence of cerebrovascular disease or signs of other neurodegenerative disease except for Parkinson’s disease

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia
- Claustrophobia

Use of medication with known P-gp influence, according to the Farmacotherapeutisch Kompas:
- Digoxine
- Dabigatran
- Everolimus
- Verapamil
- Tacrolimus
- Rosuvastatin
- Lercanidipin
- Repaglinide
- Aliskiren
- Aminoglycosides
- Vancomycine
- NSAIDs
- Acyclovir
- Trimethoprim
- Amfotericine B
- Ciprofloxacine
- H2 receptor antagonists
- Methotrexate
- St. John’s Wort
- Loperamide

Exclusion Criteria contrast-enhanced MRI:
- Metallic objects or fragments placed in the body
- Artificial metal joints or implants
- Pacemaker
- Clips/Stents in blood vessel
- Claustrophobia
- a history of mastocytosis
- Pregnancy or breastfeeding
- Kidney failure (< 45 ml/min)
- Allergy to MR contrast or dye
- Tattoo (>20cm)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified