Bordeaux University Hospital
Bordeaux, 33076, France
Location status: Recruiting
Location contact
Joachim MAZERE
CONTACT
Nicolas BALAMOUTOFF
CONTACT
NCT Number: NCT03998852
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Bordeaux, 33076, France
Location status: Recruiting
Joachim MAZERE
CONTACT
Nicolas BALAMOUTOFF
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Between 7 and 30 days after first visit
Standardized uptake value for the [18F]-FDOPA radiotracer
Time frame: First visit (Day 0)
Standardized uptake value for the [18F]-FEOBV radiotracer
Time frame: First visit (Day 0)
Apathy score from 0 to 36. Apathetic patient = score >2
Time frame: First visit (Day 0)
Beck Anxiety Inventory (BAI). Score from . Anxiety = score > 22
Time frame: First visit (Day 0)
Complementary assessment of apathy. Score from - 36 to 36. Score < - 22 : no apathy
Time frame: First visit (Day 0)
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)
The frequency of occurrence of symptoms is measured with a 4 points scale :
o = Never
Time frame: First visit (Day 0)
Fractional anisotropy measured with structural MRI
Time frame: First visit (Day 0)
Mean diffusivity measured with structural MRI
Time frame: First visit (Day 0)
Cerebral blood flow maps provided by arterial spin labeling sequences
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Acronym: ADACHOL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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