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NCT Number: NCT03345290

Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.

Cerebral glycolytic metabolism can be quantified by quantitative analysis of 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET). This allows to identify neurological diseases at an early stage of functional abnormalities, before any anatomical lesions, and to differentiate them from the "normal" brain aging. Aging mainly leads to atrophy with a decrease in cerebral metabolism in the prefrontal cortex, with consequent deterioration of cognitive processes, in particular executive functions (5).

In a population of 92 "control" subjects, investigators have already quantified the importance of the aging in frontal cortex hypometabolism. These patients were referred for a 18F-FDG PET in the follow-up of lymphoma considered to be in complete remission (PET without cerebral step), without any chemoradiotherapy within 2 months and with normal neuropsychological tests (Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Battery FAB).

However, cerebral aging can be "accelerated" by vascular risk factors, including increased central blood pressure, as investigators have recently reported in a pilot study involving elderly patients. This central pressure, which is directly linked to the cerebral micro-vascularization, can be easily measured by applanation tonometry. In this pilot study, investigators showed that a central pulse pressure equal or greater than 50 mmHg was associated with a significant frontal hypometabolism in elderly patients. This confirmed, at a stage of pre-clinical remodeling, the worse prognostic significance for this criterion, as reported in large epidemiological studies (increased risk of stroke and cardiac vascular events).

However, it is not yet known whether the level of central blood pressure interfere with the brain metabolism of younger subjects, especially with regard to aging observed throughout life. If this hypothesis is confirmed, preventive therapeutic strategies for accelerated aging, could thus integrate the monitoring of central pressure and cerebral metabolism.

The objective of this study is to determine, in a population of control subjects and on a larger scale, the impact of central blood pressure on brain metabolic aging , by using 18F-FDG PET.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years old, with written informed consent,
  • Subjects referred for 18F-FDG PET in a non-oncological setting,
  • Absence of pregnancy or breastfeeding,
  • Lack of chemotherapy in the previous year and no cerebral radiotherapy.
  • No history of psychiatric or neurological pathology.
  • Absence of treatment with psychotropic action, and absence of corticosteroids.

Exclusion criteria

  • "abnormal" neuropsychological tests:
  • Mini Mental State Examination (MMSE) <27,
  • Current major depressive episode on the Mini International Neuropsychologic Interview (MINI),
  • Frontal Assessment Battery (FAB) <15.
  • 18F-FDG PET examination showing ischemic, neurodegenerative, neoplastic or other brain lesions (independent of a normal or accelerated aging process).

Treatment and study plan

PET with a cerebral step

Device

Positron Emission Tomography with a cerebral step before to carry out the standard Position Emission Tomography

Central blood pressure measurement

Device

Central blood pressure measurement

Neurocognitive tests

Other

Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB

Primary outcomes

  1. volume of brain areas detected by quantitative analysis

    Time frame: At inclusion

  2. topography of brain areas detected by quantitative analysis

    Time frame: At inclusion

  3. central blood pressure

    Time frame: At inclusion

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: PACTEP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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