Schizophrenia Trial, Recruiting NCT07509125 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Schizophrenia
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Schizophrenia Trial, Recruiting

NCT07509125
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Healthy volunteers (Work Package 1):

  • People aged between 18 and 90 years old (the study aims to recruit 15 people aged 18–50 and 25 people aged 50–90)
  • People judged to be in good general health by the study doctor, based on medical history, physical check-up, and lab tests
  • People with no history or current signs of a major brain, nervous system, or mental health condition
  • People who score 26 or higher on a standard memory and thinking test (called the MoCA) at the start of the study
  • People under 60 years old who have a normal brain MRI scan as confirmed by a specialist radiologist
  • People aged 60 or older who have only mild or no white matter changes on their brain scan (scored 2 or below out of 3 on a standard scale)
  • People over 50 who are willing to provide a blood sample to test for a protein linked to Alzheimer's disease (called p-tau217)

People with a dementia diagnosis (Work Package 2):

  • People who have a clinical diagnosis of early-stage Alzheimer's disease confirmed by biological markers

People with ALS (motor neurone disease) (Work Package 3):

  • People who meet internationally recognised diagnostic criteria for at least a possible diagnosis of ALS (confirmed with trial site)

People with movement disorders (Work Package 4):

  • All participants in this group: people (or their legal representative, where applicable) who are able to understand the study information and provide written consent
  • Parkinson's disease: People with a clinically established Parkinson's disease diagnosis based on recognised specialist criteria, who also have an abnormal result on a specific brain scan (18F-PE2I PET), and who score 26 or higher on the MoCA thinking and memory test
  • Multiple system atrophy (MSA): People with a confirmed or probable diagnosis of a specific type of MSA (MSA-P) based on specialist criteria, who also have an abnormal 18F-PE2I PET brain scan result
  • Progressive supranuclear palsy (PSP): People with a confirmed probable PSP diagnosis based on the latest specialist criteria, and an abnormal 18F-PE2I PET brain scan result
  • Dementia with Lewy bodies (DLB): People with a probable DLB diagnosis, meaning they have cognitive difficulties (MoCA score below 26) plus visual hallucinations and/or episodes of fluctuating alertness, and an abnormal 18F-PE2I PET brain scan result
  • REM sleep behaviour disorder (iRBD): People with a confirmed diagnosis of iRBD through a specialised sleep study (polysomnography), who score 26 or higher on the MoCA test, and who show no signs of a movement disorder at the start of the study

People with psychosis (Work Package 5):

  • People who meet recognised diagnostic criteria (DSM-5) for a schizophrenia-spectrum psychotic disorder that is not caused by mood disorder
  • People aged 18–55 for adult-onset psychosis, or people aged over 60 whose psychosis began after age 60

Who may not be able to join:

  • People who have a significant other medical, neurological, or psychiatric condition that could interfere with the study (such as serious liver or kidney disease, uncontrolled diabetes, cancer, severe depression, stroke, or serious brain injury)
  • People who currently use or have a history of misusing illicit drugs (including cannabis) or alcohol
  • People who regularly take medications that affect the brain or nervous system (such as strong opioid painkillers or antipsychotics), unless those medications are prescribed specifically for the condition being studied
  • People who have already been exposed to ionising radiation above a certain level (more than 1 mSv) through other research studies in the past 12 months
  • People who have a medical reason they cannot have an MRI scan
  • People who experience claustrophobia or are unable to remain still inside a scanner for at least 60 minutes
  • People (in the subgroup requiring arterial blood sampling only) who are allergic to a local anaesthetic called lidocaine, have poor blood flow in the forearm arteries (detected by a test called the Allen test), or who take blood-thinning medication
  • People who are unable to understand what the study involves, either personally or through a legal representative
  • People who are unwilling or unable to complete all study procedures, or who the lead researcher considers unsuitable for any reason
  • People who may be pregnant (a pregnancy test may be carried out if there is any uncertainty)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +32 16 34 37 11

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
13 February 2026
Est. completion
1 September 2029

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Volume distribution (mL/cm³) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240; Standardized uptake value ratios (SUVR) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov