Aging DisorderPACTEPNCT03345290
Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.
A study testing PET with a cerebral step, Central blood pressure measurement and Neurocognitive tests in people with Aging Disorder, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging Disorder
- What is being tested?
- PET with a cerebral step, Central blood pressure measurement and Neurocognitive tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2018to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- "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).
Trial locations and contacts
1 site in 1 country.
About this 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).
Read more
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.
- Conditions
- Aging Disorder
- Being tested
- PET with a cerebral step, Central blood pressure measurement, Neurocognitive tests
- Keywords
- Aging, Central pressure, FDG PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET with a cerebral stepDevice
Positron Emission Tomography with a cerebral step before to carry out the standard Position Emission Tomography
Central blood pressure measurementDevice
Central blood pressure measurement
Neurocognitive testsOther
Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PET with a cerebral step; Device: Central blood pressure measurement; Other: Neurocognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of brain areas detected by quantitative analysis
Measured: At inclusion
topography of brain areas detected by quantitative analysis
Measured: At inclusion
central blood pressure
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start31 Jul 2018
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging DisorderStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
- Investigators
- Antoine Verger, MD, PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345290
- Sponsor's protocol ID
- PSS2016/PACTEP-VERGER/VS
- Acronym
- PACTEP
- Status last verified
- Aug 2022
- First submitted
- 10 Nov 2017
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37369917
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.
- ClinicalTrials.gov ID
- NCT03345290
- Acronym / sponsor ID
- PACTEP / PSS2016/PACTEP-VERGER/VS
- Conditions
- Aging Disorder
- Keywords
- Aging, Central pressure, FDG PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Experimental | Device: PET with a cerebral step, Device: Central blood pressure measurement, Other: Neurocognitive testsSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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.
Key exclusion criteria (5 listed)
- "abnormal" neuropsychological tests:
- 18F-FDG PET examination showing ischemic, neurodegenerative, neoplastic or other brain lesions (independent of a normal or accelerated aging process).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET with a cerebral stepPositron Emission Tomography with a cerebral step before to carry out the standard Position Emission Tomography | Device | Subjects |
| Central blood pressure measurementCentral blood pressure measurement | Device | Subjects |
| Neurocognitive testsMini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB | Other | Subjects |
Primary outcome
volume of brain areas detected by quantitative analysis
Time frame: At inclusion
topography of brain areas detected by quantitative analysis
Time frame: At inclusion
central blood pressure
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Derived from this study: PubMed 37369917Hurstel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Verger, MD, PhD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET with a cerebral step, Central blood pressure measurement and Neurocognitive tests in people with Aging Disorder, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of brain areas detected by quantitative analysis (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.