Healthy AgingTIMESNCT06349213
Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time
An observational study of Healthy Aging, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive… Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- FDOPA injection before PET imaging, Time perception tasks and fMRI imaging
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2024to 1 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participant with no diagnosed condition
Who may be able to join
- Membership of a social security scheme or beneficiary of such a scheme.
- At least 7 years' schooling.
- Acceptance and signature of the informed consent form
- Fluency in French (as assessed by the project leader)
- Age between 20 and 35 years inclusive for young healthy subjects, and between 60 and 85 years inclusive for elderly healthy subjects.
- Effective contraception for women of childbearing age: Contraception will be considered effective from the moment the participant declares taking an oral contraceptive, the presence of an IUD, diaphragm or contraceptive implant, or the performance of a tubal ligation or sterilisation.
- Absence of global cognitive deficit attested by a score on the MOCA scale greater than or equal to 26/30.
Who cannot join
- Persons under guardianship, curators or safeguard of justice.
- Pregnant women, women in labor and nursing mothers
- Chronic neurological conditions
- Uncorrected visual difficulties
- Encephalitis
- Endocrine or liver disease
Show all 14Show fewer
- History of head trauma with loss of consciousness lasting more than one hour
- History of cancer in the last 5 years, with the exception of squamous cell carcinoma of the skin
- Presence or history of chronic alcoholism or drug addiction
- Presence of clinically significant major psychiatric disorders (according to DSM-IV-TR criteria) or symptoms that could affect the participant's ability to complete the research.
- Use of medications that may modulate the dopaminergic system (psychotropic, with the exception of sleeping pills or occasional use of anxiolytics, as decided by the principal investigator).
- Contraindications to MRI examination (pregnancy; pacemaker or neurosensory stimulator or implantable defibrillator; clip on an aneurysm or clip on a vascular malformation of the brain; intraocular or cerebral ferromagnetic foreign body; prosthesis or mobilizable ferromagnetic metal object or splinter; cochlear implant ; peripheral stimulator; neurosurgical ventriculoperitoneal shunt valves; permanent eyelid or lip make-up; jewelry or piercing that cannot be removed; certain tattoos depending on the type of ink, size and location; automated injection devices such as insulin pumps, blood glucose sensors, claustrophobia).
- Radiotracer contraindications: Hypersensitivity to product excipients, chronic alcoholism, kidney disease.
- Participation in research involving exposure to ionizing radiation (nuclear medicine or radiology examinations) in the year preceding inclusion or during a period of exclusion from other research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cyceron Boulevard Henri Becquerel
Caen, 14074
MARTINAUD Olivier, Investigateur principal, + 33 2 31 06 46 17, martinaud-o@chu-caen.fr
About this study
Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments.
Read the detailed description
The main research examinations for all participants will be divided into two initial visits (V1: approximately 3.5 hours and V2: approximately 2.5 hours) at the GIP Cyceron (neuroimaging center) premises.
As part of the longitudinal follow-up, older participants only will complete one follow-up session (visits: V3, V4 and V5) of approximately two and a half hours per year at the PMRCI premises, for three years after visit 2.
During the various visits, participants may be accompanied by a support person of their choice.
The first visit will last approximately 3 and a half hours and will consist of two parts:
- First part of visit 1: Inclusion medical visit (V1, GIP Cyceron) The first part of Visit 1 will be carried out at GIP Cyceron after a cooling-off period of at least 7 days from the day of the telephone interview and will last approximately 1 hour. It will begin with the information and consent procedure carried out by an investigator registered with the Order of Physicians or his or her designated representative and registered on the task delegation list. Participants will be informed of the purpose, recipients and retention periods for all data collected as part of their participation in the research.
Prior to signing the consent form, the eligibility criteria (inclusion and non-inclusion criteria) will be checked by the investigator. The visit also includes the taking of a medical history and current treatments.
- Second part of Visit 1 (V1, GIP Cyceron): simultaneous EEG-fMRI, neuropsychological assessment : The second part of the V1 visit will be carried out at GIP Cyceron and will last approximately 2 and a half hours. It will begin with a urine pregnancy test for women of childbearing age and verification that there are no contraindications to the MRI examination. The EEG-MRI imaging will then last approximately 1.5 hours, followed by a 15-30 minute break. Finally, the neuropsychological evaluation will last about an hour and will include the performance of some of the neuropsychological tests and self-questionnaires in the presence of members of the investigating team. The tests and self-questionnaires will last approximately one hour and will be adjusted according to each individual's completion time and any level of fatigue.
During this visit, participants will perform a temporal judgement task while EEG and fMRI functional data are being recorded. Anatomical data will also be collected. The accuracy of time processing will be assessed in the MRI using bisection and temporal generalisation tasks.
Visit 2 (V2, GIP Cyceron, maximum one month after V1): PET scan and neuropsychological assessment The V2 visit will be carried out at GIP Cyceron approximately one month after visit 1 and will last about 2 and a half hours. A telephone call from the project leader will enable this visit to be scheduled. Participants will be asked to have fasted for at least 4 hours at the time of the visit, with no restriction on fluid intake. The visit will begin with PET imaging for approximately 1.5 hours, followed by a 15-30 minute break. For women of childbearing age, a urine pregnancy test will be performed prior to the PET scan. The neuropsychological assessment described in V1 will also be carried out for approximately one hour, in the presence of members of the investigating team.
The dopaminergic status of the nigrostriatal pathway will be explored in vivo using a Discovery RX VCT 64 whole-body PET-CT scanner (General Electric Healthcare; maximum axial FAV 50cm). The investigator will use [18F]-FDOPA (DOPACIS®), a fluorine-18 labelled radiopharmaceutical. This radiopharmaceutical indirectly reflects the number of dopaminergic neurons via the enzymatic activity of dopa-decarboxylase within these neurons.
Visits 3, 4, 5 (PMRCI, approximately once a year following V2):
The procedure for these three visits is identical. Participants will be contacted by the project leader to plan these visits. Only elderly participants will be included in the longitudinal follow-up. The elderly participants will first perform the temporal judgement task performed in V1 while the EEG activity is being recorded (approximately 1.5 hours). Following a 15-30 minute break, all the neuropsychological measures (tests and self-questionnaires) described above will be carried out (approximately 1.5 hours). These visits will take place one, two and three years after the second visit. Only older individuals will be included in the longitudinal follow-up in order to identify the factors associated with the variability of cognitive trajectories, which is greater during the ageing process.
At each follow-up visit (visits 3, 4 \& 5), the investigator will check that the participant is not under legal protection (guardianship, curators or safeguard of justice) as well as the absence of global cognitive deficit attested by a score on the MOCA scale greater than or equal to 26/30. If this is the case, the participant will not be able to continue to take part in the research. The tutor/supervisor will be informed of this condition.
- Conditions
- Healthy Aging
- Being tested
- FDOPA injection before PET imaging, Time perception tasks, fMRI imaging, EEG imaging, 3 year follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDOPA injection before PET imagingRadiation
Fluorodopa labelled with fluorine 18 (physical half-life of 109.6 min) is used at a dosage of 1 to 2 MBq/kg in neuroimaging, depending on the sensitivity of the PET camera used. For these reasons, a dose of 2 MBq/kg will be administered slowly intravenously (approximately 1 minute for a maximum bolus of 10 mL). PET acquisitions will be performed at 90 minutes post-injection and will last 30 minutes. Participants will be asked to have fasted for at least 4 hours at the time of injection, with no restriction on fluid intake.
Time perception tasksBehavioural
The main tasks involves the comparison of duration to assess aging effects on the precision of temporal representations
fMRI imagingDevice
Imaging of brain structure during the completion of the time perception task
EEG imagingDevice
Recording of neural dynamics during the completion of the time perception task
3 year follow-upBehavioural
Behavioral and EEG follow-up (for older adults only)
| Study group | Role | What they receive |
|---|---|---|
| Young healthy volunteers | Healthy young adults (20-35 years) will undergo the first two visits detailed above. Receives: Radiation: FDOPA injection before PET imaging; Behavioral: Time perception tasks; Device: fMRI imaging; Device: EEG imaging | |
| Older healthy volunteers | Healthy older adults (60-85 years) will undergo each visit detailed above (five visits in total). Receives: Radiation: FDOPA injection before PET imaging; Behavioral: Time perception tasks; Device: fMRI imaging; Device: EEG imaging; Behavioral: 3 year follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG phase lag index differences between group
Functional connectivity (EEG phase lag index (PLI) in each frequency band) differences between young and older adults during completion of the duration comparison task
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start20 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349213
- Sponsor's protocol ID
- C23-19
- Other IDs
- 2023-A02263-42
- Acronym
- TIMES
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time
- ClinicalTrials.gov ID
- NCT06349213
- Acronym / sponsor ID
- TIMES / C23-19
- Conditions
- Healthy Aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 5 Apr 2024 (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.
Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments.
Detailed description
The main research examinations for all participants will be divided into two initial visits (V1: approximately 3.5 hours and V2: approximately 2.5 hours) at the GIP Cyceron (neuroimaging center) premises.
As part of the longitudinal follow-up, older participants only will complete one follow-up session (visits: V3, V4 and V5) of approximately two and a half hours per year at the PMRCI premises, for three years after visit 2.
During the various visits, participants may be accompanied by a support person of their choice.
The first visit will last approximately 3 and a half hours and will consist of two parts:
- First part of visit 1: Inclusion medical visit (V1, GIP Cyceron) The first part of Visit 1 will be carried out at GIP Cyceron after a cooling-off period of at least 7 days from the day of the telephone interview and will last approximately 1 hour. It will begin with the information and consent procedure carried out by an investigator registered with the Order of Physicians or his or her designated representative and registered on the task delegation list. Participants will be informed of the purpose, recipients and retention periods for all data collected as part of their participation in the research.
Prior to signing the consent form, the eligibility criteria (inclusion and non-inclusion criteria) will be checked by the investigator. The visit also includes the taking of a medical history and current treatments.
- Second part of Visit 1 (V1, GIP Cyceron): simultaneous EEG-fMRI, neuropsychological assessment : The second part of the V1 visit will be carried out at GIP Cyceron and will last approximately 2 and a half hours. It will begin with a urine pregnancy test for women of childbearing age and verification that there are no contraindications to the MRI examination. The EEG-MRI imaging will then last approximately 1.5 hours, followed by a 15-30 minute break. Finally, the neuropsychological evaluation will last about an hour and will include the performance of some of the neuropsychological tests and self-questionnaires in the presence of members of the investigating team. The tests and self-questionnaires will last approximately one hour and will be adjusted according to each individual's completion time and any level of fatigue.
During this visit, participants will perform a temporal judgement task while EEG and fMRI functional data are being recorded. Anatomical data will also be collected. The accuracy of time processing will be assessed in the MRI using bisection and temporal generalisation tasks.
Visit 2 (V2, GIP Cyceron, maximum one month after V1): PET scan and neuropsychological assessment The V2 visit will be carried out at GIP Cyceron approximately one month after visit 1 and will last about 2 and a half hours. A telephone call from the project leader will enable this visit to be scheduled. Participants will be asked to have fasted for at least 4 hours at the time of the visit, with no restriction on fluid intake. The visit will begin with PET imaging for approximately 1.5 hours, followed by a 15-30 minute break. For women of childbearing age, a urine pregnancy test will be performed prior to the PET scan. The neuropsychological assessment described in V1 will also be carried out for approximately one hour, in the presence of members of the investigating team.
The dopaminergic status of the nigrostriatal pathway will be explored in vivo using a Discovery RX VCT 64 whole-body PET-CT scanner (General Electric Healthcare; maximum axial FAV 50cm). The investigator will use [18F]-FDOPA (DOPACIS®), a fluorine-18 labelled radiopharmaceutical. This radiopharmaceutical indirectly reflects the number of dopaminergic neurons via the enzymatic activity of dopa-decarboxylase within these neurons.
Visits 3, 4, 5 (PMRCI, approximately once a year following V2):
The procedure for these three visits is identical. Participants will be contacted by the project leader to plan these visits. Only elderly participants will be included in the longitudinal follow-up. The elderly participants will first perform the temporal judgement task performed in V1 while the EEG activity is being recorded (approximately 1.5 hours). Following a 15-30 minute break, all the neuropsychological measures (tests and self-questionnaires) described above will be carried out (approximately 1.5 hours). These visits will take place one, two and three years after the second visit. Only older individuals will be included in the longitudinal follow-up in order to identify the factors associated with the variability of cognitive trajectories, which is greater during the ageing process.
At each follow-up visit (visits 3, 4 \& 5), the investigator will check that the participant is not under legal protection (guardianship, curators or safeguard of justice) as well as the absence of global cognitive deficit attested by a score on the MOCA scale greater than or equal to 26/30. If this is the case, the participant will not be able to continue to take part in the research. The tutor/supervisor will be informed of this condition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young healthy volunteers | – | Radiation: FDOPA injection before PET imaging, Behavioral: Time perception tasks, Device: fMRI imaging, Device: EEG imagingHealthy young adults (20-35 years) will undergo the first two visits detailed above. |
| Older healthy volunteers | – | Radiation: FDOPA injection before PET imaging, Behavioral: Time perception tasks, Device: fMRI imaging, Device: EEG imaging, Behavioral: 3 year follow-upHealthy older adults (60-85 years) will undergo each visit detailed above (five visits in total). |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participant with no diagnosed condition
Key inclusion criteria (7 listed)
- Membership of a social security scheme or beneficiary of such a scheme.
- At least 7 years' schooling.
- Acceptance and signature of the informed consent form
- Fluency in French (as assessed by the project leader)
- Age between 20 and 35 years inclusive for young healthy subjects, and between 60 and 85 years inclusive for elderly healthy subjects.
Key exclusion criteria (14 listed)
- Persons under guardianship, curators or safeguard of justice.
- Pregnant women, women in labor and nursing mothers
- Chronic neurological conditions
- Uncorrected visual difficulties
- Encephalitis
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 |
|---|---|---|
| FDOPA injection before PET imagingFluorodopa labelled with fluorine 18 (physical half-life of 109.6 min) is used at a dosage of 1 to 2 MBq/kg in neuroimaging, depending on the sensitivity of the PET camera used. For these reasons, a dose of 2 MBq/kg will be administered slowly intravenously (approximately 1 minute for a maximum bolus of 10 mL). PET acquisitions will be performed at 90 minutes post-injection and will last 30 minutes. Participants will be asked to have fasted for at least 4 hours at the time of injection, with no restriction on fluid intake. | Radiation | Older healthy volunteers, Young healthy volunteers |
| Time perception tasksThe main tasks involves the comparison of duration to assess aging effects on the precision of temporal representations | Behavioural | Older healthy volunteers, Young healthy volunteers |
| fMRI imagingImaging of brain structure during the completion of the time perception task | Device | Older healthy volunteers, Young healthy volunteers |
| EEG imagingRecording of neural dynamics during the completion of the time perception task | Device | Older healthy volunteers, Young healthy volunteers |
| 3 year follow-upBehavioral and EEG follow-up (for older adults only) | Behavioural | Older healthy volunteers |
Primary outcome
EEG phase lag index differences between group
Time frame: Through study completion, an average of 3 years
Functional connectivity (EEG phase lag index (PLI) in each frequency band) differences between young and older adults during completion of the duration comparison task
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by Institut National de la Santé Et de la Recherche Médicale, 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Hinault, PhD (+33231568140, thomas.hinault@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG phase lag index differences between group (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.