A Phase 3 interventional study of Positron Emission Tomography (PET) with [18F]-FDOPA and Positron Emission Tomography (PET) with [18F]-FEOBV in Apathy, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Diagnostic
Apathy is a neurocognitive syndrome characterized by reduced goal-directed behaviors, contributing to decreased patient and caregiver quality of life. Apathy pathophysiology involves disruption of cortico-striato-thalamo-cortical loops, modulated by several neurotransmitter systems including dopamine and acetylcholine, thus complexifying pharmacological management. Post-stroke apathy (PSA) can provide a proper in vivo model to study the underlying neurochemical substrates of apathy as a syndrome. The present project aims to provide a better characterization of the cholinergic and dopaminergic functioning in apathy as a syndrome.
In order to precise the respective alterations of these two systems, investigators will use a positron emission tomography (PET) molecular imaging of dopaminergic (with [18F]-FDOPA, a marker of the decarboxylating enzyme of dopamine) and - for the first time in apathetic patients - cholinergic (with [18F]-FEOBV, a marker of the vesicular acetylcholine transporter) transmissions in 15 apathetic and 15 unapathetic patients 3 months after stroke, without overlapping depression. This dual imaging study may provide help in guiding therapeutic management of PSA. The functional network analysis allowed by functional MRI is crucial to complement regional neurotransmitter deficits observed with PET. Altogether, a multimodal approach in apathy, combining PET and MRI, can allow identifying which circuits of the cortico-striato-thalamo-cortical loops are disrupted and how these circuits are modulated by other neurotransmitters.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Positron Emission Tomography (PET) molecular imaging of dopaminergic and cholinergic systems using two radiotracers
Drug: Positron Emission Tomography (PET) with [18F]-FDOPA · Drug: Positron Emission Tomography (PET) with [18F]-FEOBV · Device: Magnetic Resonnance Imaging (MRI) · Other: Neuropsychological evaluation
Positron Emission Tomography (PET) with \[18F\]-FDOPA
Positron Emission Tomography (PET) with \[18F\]-FEOBV
MRI protocol will be performed on the same day that the \[18F\]-FEOBV PET imaging, using a 3T scanner (Philips Medical System). Different types of images will be acquired.
Neuropsychological evaluation will be performed, consisting in an assessment of apathy by actigraphy (social or physical activities will be recorded during seven days) and a complementary assessment of apathy using the Lille Apathy Rating Scale (LARS)
[18F]-FDOPA SUVr
Standardized uptake value for the \[18F\]-FDOPA radiotracer
Time frame: Between 7 and 30 days after first visit
[18F]-FEOBV SUVr
Standardized uptake value for the \[18F\]-FEOBV radiotracer
Time frame: First visit (Day 0)
Apathy Inventory Score
Apathy score from 0 to 36. Apathetic patient = score \>2
Time frame: First visit (Day 0)
Beck Anxiety Inventory (BAI) Score
Beck Anxiety Inventory (BAI). Score from . Anxiety = score \> 22
Time frame: First visit (Day 0)
Lille Apathy Rating Scale (LARS) Score
Complementary assessment of apathy. Score from - 36 to 36. Score \< - 22 : no apathy * 21 to -17 : apathy tendancy * 16 to -10 : moderate apathy * 9 to 36 : severe apathy
Time frame: First visit (Day 0)
Multidimensional Fatigue Inventory (MFI) Score
The MFI contains 20 items classified into four dimensions : general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from "Yes, that is true" to "No, that is not true") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue.
Time frame: First visit (Day 0)
Center of Epidemiology Studies Depression Scale (CES-D) Score
Center of Epidemiology Studies Depression Scale (CES-D) The frequency of occurrence of symptoms is measured with a 4 points scale : o = Never 1. = Occasionally 2. = Quite often 3. = Frequently The total score is between 0 and 60. Highest scores correspond to the presence of a more severe depressive symptomatology Depressive patients = score \> 17 for men and \>23 for women
Time frame: First visit (Day 0)
Fractional anisotropy
Fractional anisotropy measured with structural MRI
Time frame: First visit (Day 0)
Mean diffusivity
Mean diffusivity measured with structural MRI
Time frame: First visit (Day 0)
Cerebral blood flow maps
Cerebral blood flow maps provided by arterial spin labeling sequences
Time frame: First visit (Day 0)
Started Apr 2021 (actual). Primary completion is estimated for Apr 2027, 72 months after the start.
Of 92 non-industry phase 3 interventional studies under Stroke, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 72 months is above that.
Counting every sponsor, half of 129 studies reached it within 44 months; a quarter within 27 and three quarters within 68.
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