Alzheimer Dementia (AD)NCT07509125
Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders
A study testing UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-PE2I and UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1 in people with Alzheimer Dementia (AD) and ALS - Amyotrophic Lateral Sclerosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The goal of this study is to use ultra-high-resolution (UHR) PET imaging to better understand how the brain and spinal cord change in healthy aging and in neurological and psychiatric disorders such as Alzheimer's disease (AD), Parkinson's disease and related movement disorders, amyotrophic lateral sclerosis (ALS)… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis, Parkinson s Disease
- What is being tested?
- UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-PE2I and UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Feb 2026to Sep 2029
- Phase
- Interventional
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- WP1: Healthy controls
- Age between 18 and 90 years old (15 aged 18-50 years and 25 aged 50 90 years);
- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests;
- No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment;
- No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;
- In subjects < 60 years of age, a normal structural MRI scan as assessed by expert radiologist.
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- In subjects >= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score <= 2 (of 3) on the Age-Related White Matter changes scale are acceptable;
- When older than 50 years of age, the volunteer is willing to undergo a p- tau217 blood sample.
- WP2: Dementia
- Patient has a clinical diagnosis of biomarker-proven prodromal AD
- WP3: ALS spectrum
- Subject must meet El Escorial Criteria (30) and Awaji-Shima criteria (31) for at least possible ALS;
- WP4: Movement disorders
- (all): Patient (or legal representative, when applicable) is able to understand the patient information form and give written informed consent.
- Parkinson´s disease (PD):
- Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria (32);
- Patient has an abnormal 18F-PE2I PET;
- No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline.
- Multiple system atrophy (MSA)
- Patient has clinically established or clinically probable MSA-P based on the
- Movement Disorder Society (MDS) diagnostic criteria (33);
- Patient has an abnormal 18F-PE2I PET.
- Progressive supranuclear palsy (PSP)
- Patient has an abnormal 18F-PE2I PET;
- Patient has clinically established probable PSP according to the latest MDS criteria
- Dementia with Lewy bodies (DLB)
- Patient has probable DLB by consensus criteria (cognitive impairment MoCA < 26 + visual hallucinations and/or fluctuating alertness);
- Patient has an abnormal 18F-PE2I PET.
- Idiopathic REM sleep behavior disorder (iRBD)
- Patient has Polysomnography-confirmed iRBD;
- No evidence of cognitive impairment as assessed by a Montreal Cognitive Assessment (MoCA) score of 26 or higher at baseline;
- No clinical evidence of parkinsonism at baseline.
- WP5: Psychosis
- DSM 5 criteria for a non-affective schizophrenia spectrum psychotic disorder;
- Age between 18 and 55 years old for adult-onset psychosis, onset of psychosis (and age) above 60 years old for very late onset psychosis.
Who cannot join
- Subject has a history of any major (other) internal, psychiatric or neurological disease that may interfere with the investigations (especially liver and kidney disease, uncontrolled diabetes, cancer, severe depression, stroke, severe TBI);
- Subject is currently a user (including recreational use) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse;
- Subject chronically uses medication that has central nervous system effects (e.g. strong painkillers such as opioids, neuroleptics,..; ) (other than prescribed for the illness in case of patients);
- Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months;
- Subject has a contra-indication for MRI scanning;
- Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for (at least) 60 minutes inside the scanner;
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- (For subjects with arterial sampling): The subject is hypersensitive to lidocaine (used for local anaesthesia during the placement of the arterial catheter), has an abnormal Allen test (a test to check blood flow in the arteries of the forearm) or is on anti-coagulant therapy;
- Subject (or his/her legal representative) does not understand the study procedures;
- Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;
- Subject is potentially pregnant (hCG test can be done if doubt exists).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Koen Van Laere, Prof. Dr., +32 16 34 37 11, koen.vanlaere@uzleuven.be
About this study
Official title: Ultra-High Resolution PET of the Human Brain and Spinal Cord in Healthy Aging, Dementia, Movement Disorders, ALS and Psychotic Disorders
The goal of this study is to use ultra-high-resolution (UHR) PET imaging to better understand how the brain and spinal cord change in healthy aging and in neurological and psychiatric disorders such as Alzheimer's disease (AD), Parkinson's disease and related movement disorders, amyotrophic lateral sclerosis (ALS), and psychotic disorders. Researchers will use the NeuroExplorer PET/CT system, a new scanner that can show very small structures in the brain and spinal cord in much more detail than regular PET.
The main questions this study aims to answer are:
Read more
- How do small but important brain regions (like the locus coeruleus, substantia nigra, and thalamic nuclei) change in healthy aging?
- What early brain changes occur in neurodegenerative and psychotic disorders, and can they help improve early diagnosis?
Participants will:
- Undergo PET and MRI brain scans using different tracers that measure brain metabolism (18F-FDG), synaptic density (¹⁸F-SynVesT-1), dopamine transporters (¹⁸F-PE2I), and tau protein buildup (¹⁸F-MK6240).
- Complete cognitive and clinical assessments related to memory, mood, and motor or psychiatric symptoms, depending on their group.
This study will include healthy volunteers and patients with mild cognitive impairment due to Alzheimer´s disease, ALS, Parkinson's disease and related disorders, or psychotic disorders.
The results will help create detailed brain imaging maps for healthy aging and identify early biomarkers for different diseases to support better diagnosis and treatment in the future.
- Conditions
- Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis, Parkinson s Disease, REM Sleep Behavior Disorder (iRBD), PSP - Progressive Supranuclear Palsy, MSA - Multiple System Atrophy
- Being tested
- UHR PET/CT scan of the brain with ¹⁸F-FDG, UHR PET/CT scan of the brain with ¹⁸F-PE2I, UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1, UHR PET/CT scan of the brain with ¹⁸F-MK6240, 3T MRI imaging of the brain
- Keywords
- PET/CT scan, Alzheimer´s disease, Dementia, Amyotrophic Lateral Sclerosis, Parkinson´s disease, REM sleep behavior disorders, Progressive supranuclear palsy, Multiple System Atrophy, Dementia with Lewy Bodies, Psychotic disorders, Schizophrenia, ALS with frontotemporal dementia, UHR PET, Locus coeruleus, Papez circuit, Thalamic subnuclei
- Medical subject headings
- Alzheimer Disease, Amyotrophic Lateral Sclerosis, Parkinson Disease, REM Sleep Behavior Disorder, Supranuclear Palsy, Progressive, Shy-Drager Syndrome, Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHR PET/CT scan of the brain with ¹⁸F-FDGOther
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-FDG radiotracer to assess glucose metabolism
UHR PET/CT scan of the brain with ¹⁸F-PE2IOther
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-PE2I radiotracer to assess dopaminergic activity
UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1Other
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-SynVesT-1 radiotracer to assess synaptic density
UHR PET/CT scan of the brain with ¹⁸F-MK6240Other
Ultra-high-resolution PET/CT imaging of the brain on the NeuroEXPLORER system using ¹⁸F-MK6240 radiotracer to assess neurofibrillary tangles
3T MRI imaging of the brainOther
All participants will undergo 3T MRI, including T1- and FLAIR-weighted sequences for anatomical reference and white matter pathology, neuromelanin-sensitive imaging to assess SN and LC integrity, and multi-shell diffusion-weighted imaging (DWI) for white matter tractography.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Other | Participants in this arm are healthy controls undergoing ultra-high-resolution (UHR) PET imaging on the NeuroEXPLORER system using multiple radiotracers (¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240), in combination with 3T MRI. No therapeutic intervention is administered. Receives: Other: UHR PET/CT scan of the brain with ¹⁸F-FDG; Other: UHR PET/CT scan of the brain with ¹⁸F-PE2I; Other: UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1; Other: UHR PET/CT scan of the brain with ¹⁸F-MK6240; Other: 3T MRI imaging of the brain |
| Patient with aMCI | Other | Participants in this arm are patients with biomarker-confirmed amnestic mild cognitive impairment due to Alzheimer's disease undergoing UHR PET imaging using ¹⁸F-FDG and ¹⁸F-MK6240, in combination with 3T MRI. No therapeutic intervention is administered. Receives: Other: UHR PET/CT scan of the brain with ¹⁸F-FDG; Other: UHR PET/CT scan of the brain with ¹⁸F-MK6240; Other: 3T MRI imaging of the brain |
| Patients with ALS/ALS-FTD | Other | Participants in this arm are patients within the ALS and ALS-FTD spectrum undergoing UHR PET imaging using ¹⁸F-FDG, with a subgroup additionally undergoing ¹⁸F-SynVesT-1 PET, in combination with 3T MRI. No therapeutic intervention is administered. Receives: Other: UHR PET/CT scan of the brain with ¹⁸F-FDG; Other: UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1; Other: 3T MRI imaging of the brain |
| Patients with movement disorders | Other | Participants in this arm include patients with Parkinson's disease, atypical parkinsonism, dementia with Lewy bodies or idiopathic REM sleep behavior disorder undergoing UHR PET imaging using ¹⁸F-FDG, ¹⁸F-PE2I and ¹⁸F-SynVesT-1, in combination with 3T MRI. No therapeutic intervention is administered. Receives: Other: UHR PET/CT scan of the brain with ¹⁸F-FDG; Other: UHR PET/CT scan of the brain with ¹⁸F-SynVesT-1; Other: 3T MRI imaging of the brain |
| Patients with psychotic disorders | Other | Participants in this arm are patients with adult-onset or very late-onset psychotic disorders undergoing UHR PET imaging using ¹⁸F-FDG, in combination with 3T MRI. No therapeutic intervention is administered. Receives: Other: UHR PET/CT scan of the brain with ¹⁸F-FDG; Other: 3T MRI imaging of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume distribution (mL/cm³) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240
To evaluate the regional binding patterns in small brain nuclei using four PET tracers (18F-FDG, 18F-PE2I, 18F-SynVest-1, 18F-MK6240) in different subject groups (healthy controls and disease cohorts). Quantitative outcome metrics will include distribution volumes with and without partial volume correction (PVC).
Measured: Through study completion, an average of 4 year
Standardized uptake value ratios (SUVR) in small brain nuclei of tracers ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVesT-1 and ¹⁸F-MK6240
To evaluate the regional binding patterns in small brain nuclei using four PET tracers (18F-FDG, 18F-PE2I, 18F-SynVest-1, 18F-MK6240) in different subject groups (healthy controls and disease cohorts). Quantitative outcome metrics will include standardized uptake value ratios (SUVR) with and without partial volume correction (PVC).
Measured: Through study completion, an average of 4 year
Secondary outcomes (2)
Correlation between regional PET tracer uptake and cognitive performance
Quantitative PET measures (SUVR from ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVest-1, and ¹⁸F-MK6240) will be correlated with cognitive performance across disease cohorts.
Cognitive outcomes will be assessed using standardized neuropsychological tests covering global cognition, memory, language, executive function, and attention.
Examples include the Montreal Cognitive Assessment (MoCA) (0-30, a higher score indicating a better outcome), Boston Naming Test (BNT) (0-60, a higher score indicating a better outcome) and Raven's Coloured Progressive Matrices (RCPM) (0-24, a higher score indicating a better outcome)
Measured: Through study completion, an average of 4 year
Correlation between regional PET tracer uptake and motor and functional impairment
Quantitative PET measures (SUVR from ¹⁸F-FDG, ¹⁸F-PE2I, ¹⁸F-SynVest-1, and ¹⁸F-MK6240) will be correlated with motor and functional outcome measures, including performance across disease cohorts. Cognitive outcomes will be assessed using standardized clinical rating scales such as the MDS-UPDRS (all items scored between 0-4, with a higher score indicative of a higher symptom severity)
Measured: Through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start13 Feb 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Depending on the work package, patients under 50 years old will receive a combination of 2 different tracers, and those above 50 years old an optional additional 3th tracer
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509125
- Sponsor's protocol ID
- S71328
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li H, Badawi RD, Cherry SR, Fontaine K, He L, Henry S, Hillmer AT, Hu L, Khattar N, Leung EK, Li T, Li Y, Liu C, Liu P, Lu Z, Majewski S, Matuskey D, Morris ED, Mulnix T, Omidvari N, Samanta S, Selfridge A, Sun X, Toyonaga T, Volpi T, Zeng T, Jones T, Qi J, Carson RE. Performance Characteristics of the NeuroEXPLORER, a Next-Generation Human Brain PET/CT Imager. J Nucl Med. 2024 Aug 1;65(8):1320-1326. doi: 10.2967/jnumed.124.267767.
PubMed 38871391Omidvari N, Shanina E, Leung EK, Sun X, Li Y, Mulnix T, Gravel P, Henry S, Matuskey D, Volpi T, Jones T, Badawi RD, Li H, Carson RE, Qi J, Cherry SR. Quantitative Accuracy Assessment of the NeuroEXPLORER for Diverse Imaging Applications: Moving Beyond Standard Evaluations. J Nucl Med. 2025 Jan 3;66(1):150-157. doi: 10.2967/jnumed.124.268309.
PubMed 39638433