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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49215

Enrollment

Registered

2020-07-02

Start date

2020-11-02

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1. Administration of radiopharmacon [18F]MC225 2. Arterial and venous plasma sampling 3. Administration of one gift Cyclosporin (registered pharmaceutical) to cause inhibition of p-gp function in fi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers aged 50-80.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Tracer uptake values in several brain regions of interest (ROIs), representing local BBB P-gp efflux function with and without inhibition of the P-gp function by Cyclosporin-A, to validate the tracer as specific P-gp substrate.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)