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

Not Applicable

Completed

• Conditions: Aging Disorder
• Interventions: Device: PET with a cerebral step; Device: Central blood pressure measurement; Other: Neurocognitive tests

• Registration Number: NCT03345290
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-17
• Study Start: 2018-07-31
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	Central blood pressure measurement	Subjects referred to a FDG PET scan (standard PET without cerebral step) without any oncologic setting. Patients will be included as following critera: 25% of subjects will have under 40 years old, 25% between 40 and 60 yeard old et 50% higher than 60 years old.
Subjects	Neurocognitive tests	Subjects referred to a FDG PET scan (standard PET without cerebral step) without any oncologic setting. Patients will be included as following critera: 25% of subjects will have under 40 years old, 25% between 40 and 60 yeard old et 50% higher than 60 years old.
Subjects	PET with a cerebral step	Subjects referred to a FDG PET scan (standard PET without cerebral step) without any oncologic setting. Patients will be included as following critera: 25% of subjects will have under 40 years old, 25% between 40 and 60 yeard old et 50% higher than 60 years old.

Primary Outcome Measures

Name	Time	Method
volume of brain areas detected by quantitative analysis	At inclusion
topography of brain areas detected by quantitative analysis	At inclusion
central blood pressure	At inclusion

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Vandoeuvre les Nancy, France