[18F]MC225-PET: Assessment of the blood-brain barrier integrity and P-glycoprotein function in healthy volunteers,a pilot study

Phase 2

Recruiting

Conditions: Alzheimer's dementia
Alzheimer's disease
blood brain barrier dysfunction which is involved in Alzheimer's disease
10029305

Registration Number: NL-OMON49215

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Healthy volunteers aged 50-80.

Exclusion Criteria

- Past history of neuropsychiatric disorders such as epilepsy, major
depression, or schizophrenia
- Subjects who are currently taking prescription drugs with an influence on
P-gp function, general pharmaceuticals
- Exhibition to a radiation dose for other reasons, exceeding the maximum
annual dose.
- Contra-indication for MRI-scanning (metal parts in the body, insuline pump,
pacemaker, claustrophobia)
- Disturbed kidney function with eGFR<60

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tracer uptake values in several brain regions of interest (ROIs), representing<br /><br>local BBB P-gp efflux function with and without inhibition of the P-gp function<br /><br>by Cyclosporin-A, to validate the tracer as specific P-gp substrate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Arterial sampling will be assessed, and based on advanced kinetic modelling<br /><br>approaches the most suitable scan analysis model with least necessary blood<br /><br>sampling will be chosen for further studies in Alzheimer*s patients and<br /><br>patients diagnosed with MCI.<br /><br>2. In five subjects a test-retest study will be performed, in order to correct<br /><br>for scan variability<br /><br>3. A [15O]H2O-PET scan will be performed to measure the effect of cerebral<br /><br>blood flow on the brain uptake of [18F]MC225. If [18F]MC225 uptake proves to<br /><br>be independent of blood flow measures, this extra scan can be left out in<br /><br>further studies.<br /><br>4. MRI VAI measures of blood-brain barrier integrity will be compared to BBB<br /><br>dynamic P-gp function, to evaluate the influence of microvascular disturbances<br /><br>on tracer uptake</p><br>