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ApathyPhase 3ADACHOLNCT03998852

In Vivo Involvement of the Cholinergic and Dopaminergic Systems in the Pathophysiology of Apathy.

A Phase 3 study testing Positron Emission Tomography (PET) with [18F]-FDOPA, Positron Emission Tomography (PET) with [18F]-FEOBV and Magnetic Resonnance Imaging (MRI) in people with Apathy, run by University Hospital, Bordeaux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Apathy
What is being tested?
Positron Emission Tomography (PET) with [18F]-FDOPA, Positron Emission Tomography (PET) with [18F]-FEOBV and Magnetic Resonnance Imaging (MRI)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
13 Apr 2021to 13 May 2027
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient of legal age and younger than 75 years
  • Patient with a Rankin score less then or equal to 2 and with or without apathy, demonstrated by AI scales at 3 months after stroke (apathetic patient = AI scale score > 2)
  • Affiliate or beneficiary of a social security scheme
  • Subjects (female study subjects and female partners of male participants) using highly effective contraceptive methods (intra-uterine device, progestin or estrogen-progestin contraceptive, sterilization)
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)

Who cannot join

  • Patients over 75 years old
  • Taking of any pharmacological treatment likely to affect cholinergic systems at the time of PET-scan: Amitriptyline, Atropine, Brompheniramine, Chlorphenamine, Chlorpromazine, Clomipramine, Clozapine, Dimenhydrinate, Diphenhydramine, Doxepine, Hyoscyamine, Imipramine, Meclozine, Nortriptyline, Oxybutynine, Promethazine, Scopolamine, Trimipramine, Hydroxyzine.
  • Taking of any pharmacological treatment likely to affect dopaminergic systems at the time of PET-scan: glucagon, haloperidol, reserpin
  • Taking of any selective serotonine reuptake inhibitors treatment
  • White matter T2 hyperintense lesions (Fazekas score > 3)
  • NYHA Class III to IV Heart Failure Patient
Show all 18Show fewer
  • Patients with allergy or conter-indication to entacapone
  • Subjects with positive pregnancy test (BHCG dosage and Urine dipstick), and/or currently breast-feeding
  • Patients unable to come back to hospital for at least 2-follow-up visits
  • Patient with a chronic neurological disorder or severe psychiatric disorder
  • Patient with cognitive impairment (MoCA<24) and depression (CES-D score > 17 for men and >23 for women)
  • Patient presenting a counter-indication for MRI
  • Patient presenting a counter-indication for TEP with [18F]-FEOBV or [18F]-FDOPA (known allergy)
  • Patient who underwent a PET examination in the previous month
  • Patient with state of health not allowing a displacement in the department of imaging of the CHU: bedridden state, state of health very deteriorated
  • Patient deprived of liberty by judicial or administrative decision
  • Patient under legal protection or unable to express its own consent
  • Subject within exclusion period from another clinical trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas BALAMOUTOFF contact

05 56 79 55 40

nicolas.balamoutoff@chu-bordeaux.fr

France1 site, 1 recruiting

  • Bordeaux University Hospital

    Bordeaux, 33076

    Nicolas BALAMOUTOFF, 05 56 79 55 40, nicolas.balamoutoff@chu-bordeaux.fr

    Joachim MAZERE, 05 57 65 64 08, joachim.mazere@chu-bordeaux.fr

    Recruiting

Other trials in France

About this study

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.

Conditions
Apathy
Being tested
Positron Emission Tomography (PET) with [18F]-FDOPA, Positron Emission Tomography (PET) with [18F]-FEOBV, Magnetic Resonnance Imaging (MRI), Neuropsychological evaluation
Keywords
Apathy, Stroke, Cholinergic neurotransmission, Dopaminergic neurotransmission
Medical subject headings
Lethargy, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positron Emission Tomography (PET) with [18F]-FDOPADrug

    Positron Emission Tomography (PET) with [18F]-FDOPA

  • Positron Emission Tomography (PET) with [18F]-FEOBVDrug

    Positron Emission Tomography (PET) with [18F]-FEOBV

  • Magnetic Resonnance Imaging (MRI)Device

    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 evaluationOther

    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)

Study groups in NCT03998852
Study groupRoleWhat they receive
Molecular imagingExperimentalPositron Emission Tomography (PET) molecular imaging of dopaminergic and cholinergic systems using two radiotracers
Receives: Drug: Positron Emission Tomography (PET) with [18F]-FDOPA; Drug: Positron Emission Tomography (PET) with [18F]-FEOBV; Device: Magnetic Resonnance Imaging (MRI); Other: Neuropsychological evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [18F]-FDOPA SUVr

    Standardized uptake value for the [18F]-FDOPA radiotracer

    Measured: Between 7 and 30 days after first visit

  2. [18F]-FEOBV SUVr

    Standardized uptake value for the [18F]-FEOBV radiotracer

    Measured: First visit (Day 0)

Secondary outcomes (8)

  1. Apathy Inventory Score

    Apathy score from 0 to 36. Apathetic patient = score >2

    Measured: First visit (Day 0)

  2. Beck Anxiety Inventory (BAI) Score

    Beck Anxiety Inventory (BAI). Score from . Anxiety = score > 22

    Measured: First visit (Day 0)

  3. 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

    Measured: First visit (Day 0)

  4. 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.

    Measured: First visit (Day 0)

  5. 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 :

    • = 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

    Measured: First visit (Day 0)

  6. Fractional anisotropy

    Fractional anisotropy measured with structural MRI

    Measured: First visit (Day 0)

  7. Mean diffusivity

    Mean diffusivity measured with structural MRI

    Measured: First visit (Day 0)

  8. Cerebral blood flow maps

    Cerebral blood flow maps provided by arterial spin labeling sequences

    Measured: First visit (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study start13 Apr 2021
  3. Primary completion13 Apr 2027 (estimated)
  4. Study completion13 May 2027 (estimated)

Resources

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03998852
Sponsor's protocol ID
CHUBX 2017/22
Acronym
ADACHOL
Status last verified
May 2026
First submitted
20 Jun 2019
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Positron Emission Tomography (PET) with [18F]-FDOPA, Positron Emission Tomography (PET) with [18F]-FEOBV and Magnetic Resonnance Imaging (MRI) in people with Apathy, run by University Hospital, Bordeaux 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 5 inclusion and 18 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 10 Jun 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Nicolas BALAMOUTOFF (05 56 79 55 40, nicolas.balamoutoff@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[18F]-FDOPA SUVr (time frame: Between 7 and 30 days after first visit). The study lists 2 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 NCT03998852.

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 10 Jun 2026.

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