NCT03345290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

November 10, 2017

Last Update Submit

August 23, 2022

Conditions

Keywords

AgingCentral pressureFDG PET

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Subjects

EXPERIMENTAL

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.

Device: PET with a cerebral stepDevice: Central blood pressure measurementOther: Neurocognitive tests

Interventions

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

Subjects

Central blood pressure measurement

Subjects

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

Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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.

You may not qualify if:

  • "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.
  • F-FDG PET examination showing ischemic, neurodegenerative, neoplastic or other brain lesions (independent of a normal or accelerated aging process).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Hurstel M, Joly L, Imbert L, Zimmermann G, Roch V, Schoepfer P, Lamiral Z, Salvi P, Benetos A, Verger A, Marie PY. Volume of the proximal half of the thoracic aorta is the most comprehensive FDG-PET/CT indicator of arterial aging throughout adulthood. Eur J Hybrid Imaging. 2023 Jun 28;7(1):11. doi: 10.1186/s41824-023-00169-2.

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Antoine Verger, MD, PhD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

July 31, 2018

Primary Completion

November 6, 2020

Study Completion

November 6, 2020

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations