Alzheimer's DiseaseNCT07906054
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
An observational study of Alzheimer's Disease and Healthy Adult Participants, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
AIM: to investigate the relationship between synaptic density, tau and reactive astrogliosis in Alzheimer's disease (AD) versus healthy controls and centenarians. DESIGN: this cross-sectional study will recruit patients with biomarker-proven AD, age- and sex-matched healthy controls as well as centenarians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy Adult Participants
- What is being tested?
- 18F-SMBT-1 PET, 18F-SynVesT-1 PET and 18F-MK-6240 PET
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to Oct 2029
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Alzheimer's disease will be recruited from the memory clinic of the University Hospitals Leuven (UZ Leuven). Centenarians will be recruited from the 100-plus study at UMC Amsterdam. Healthy controls will be recruited through internet advertisements.
Who may be able to join
- Patient has a clinical diagnosis of biomarker proven AD (prodromal AD or dementia due to AD).
- Patient has an mini-mental state examination (MMSE) score of 15 or higher.
- Patient or legal representative is able to understand the patient information brochure and give written informed consent.
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Participant is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.
- No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment (Geriatric depression scale (GDS) and Beck's depression inventory (BDI)).
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- A normal structural MRI scan with respect to the participant's age as assessed by expert radiologist.
- Participant has to be at least 40 years old
- Participant is included in the 100-plus study at Amsterdam UMC.
- Participant or legal representative is able to understand the information brochure and give written informed consent.
Who cannot join
- Patient has a history of any major other disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator.
- Patient is on anti-amyloid therapy.
- Patient has contra indications for magnetic resonance imaging (MRI).
- Patient is a current smoker.
- Patient is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
- Healthy control participants
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- Participant has a history of any major disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator (especially diabetes mellitus, heart disease, liver and kidney disease, or most forms of cancer).
- Participant is a smoker or has a recent history of smoking.
- Participant has a history or evidence of psychiatric disease.
- Participant is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
- Participant has a contra-indication for MRI scanning.
- Participant suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures. Subject cannot lie still for at least 30 minutes inside a scanner.
- Participant does not understand the study procedures.
- Participant is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
- Participant is pregnant or is breastfeeding.
- Centenarians
- Participant has a history of any major disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator (especially diabetes mellitus, heart disease, liver and kidney disease, or most forms of cancer).
- Participant is a current smoker.
- Participant is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
- Participant has contra indications for MRI or cannot lie still in the scanner for 30 minutes.
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
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Koen Van Laere, Prof., +3216343715, koen.vanlaere@uzleuven.be
About this study
Official title: Prospective in Vivo Ultra-high-performance PET Imaging of Synaptic Density, Reactive Astrogliosis and Tau Accumulation in Alzheimer's Disease, Healthy Controls and Centenarians and Relationship With Fluid Biomarkers
AIM: to investigate the relationship between synaptic density, tau and reactive astrogliosis in Alzheimer's disease (AD) versus healthy controls and centenarians.
DESIGN: this cross-sectional study will recruit patients with biomarker-proven AD, age- and sex-matched healthy controls as well as centenarians. All subjects will undergo a neuropsychological evaluation and ultra-high-performance PET imaging sessions with 18F-SynVesT-1 (synaptic density), 18F-MK6240 (tau) and 18F-SMBT-1 (reactive astrogliosis) as well as structural and diffusion MRI. Blood samples will be taken for the evaluation of blood-based biomarkers.
- Conditions
- Alzheimer's Disease, Healthy Adult Participants
- Being tested
- 18F-SMBT-1 PET, 18F-SynVesT-1 PET, 18F-MK-6240 PET
- Keywords
- PET, MRI, Tau, SV2A, MAO-B, Synaptic density, Reactive astrogliosis, 18F-MK6240, 18F-SynVesT-1, 18F-SMBT-1
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-SMBT-1 PETOther
Ultra-high-performance positron emission tomography (PET) of monoamine oxidase B (MAO-B) using the radioligand 18F-SMBT-1 on the NeuroEXPLORER PET scanner.
18F-SynVesT-1 PETOther
Ultra-high-performance positron emission tomography (PET) of synaptic vesicle glycoprotein 2A (SV2A, synaptic density) using the radioligand 18F-SynVesT-1 on the NeuroEXPLORER PET scanner.
18F-MK-6240 PETOther
Ultra-high-performance positron emission tomography (PET) of tau neurofibrillary tangles using the radioligand 18F-MK6240 on the NeuroEXPLORER PET scanner.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AD | Not described Receives: Other: 18F-SMBT-1 PET; Other: 18F-SynVesT-1 PET; Other: 18F-MK-6240 PET | |
| Healthy control participants | Not described Receives: Other: 18F-SMBT-1 PET; Other: 18F-SynVesT-1 PET; Other: 18F-MK-6240 PET | |
| Centenarians | Not described Receives: Other: 18F-SMBT-1 PET; Other: 18F-SynVesT-1 PET; Other: 18F-MK-6240 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between tau, synaptic density and reactive astrogliosis
Mediation and correlation analyses will be performed to investigate the correlation between tau, synaptic density and reactive astrogliosis PET measures as quantified by standardized uptake value ratios (SUVR).
Measured: Baseline
Changes in synaptic density, tau and reactive astrolgiosis between AD patients, controls and centenarians
Synaptic density, tau and reactive astrolgiosis PET measures, as quantified by standardized uptake value ratios (SUVR), will be compared across the three different groups: patients with AD, healthy control participants and centenarians.
Measured: Baseline
Secondary outcomes (3)
Correlation of synaptic density, tau and reactive astrogliosis with diffusion MRI
The correlation of synaptic density, tau and reactive astrolgiosis PET, as quantified by standardized uptake value ratios (SUVR) in typical regions, with diffusion MRI metrics (fibre density and fibre cross-section) in the connecting white matter bundles will be assessed.
Measured: Baseline
Correlation of synaptic density, tau and reactive astrogliosis with blood-based biomarkers
The correlation of synaptic density, tau and reactive astrogliosis PET measures, as quantified by standardized uptake value ratios (SUVR), with blood-based markers of synaptic integrity and reactive astrogliosis will be assessed.
Measured: Baseline
Correlation of synaptic density, tau and reactive astrogliosis with cognitive performance
The correlation of synaptic density, tau and reactive astrolgiosis PET measures, as quantified by standardized uptake value ratios (SUVR), with neuropsychological test scores will be assessed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 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
- NCT07906054
- Sponsor's protocol ID
- S72313
- Other IDs
- SAO-FRA20250007
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective in Vivo Ultra-high-performance PET Imaging of Synaptic Density, Reactive Astrogliosis and Tau Accumulation in Alzheimer's Disease, Healthy Controls and Centenarians and Relationship With Fluid Biomarkers
- ClinicalTrials.gov ID
- NCT07906054
- Acronym / sponsor ID
- S72313
- Conditions
- Alzheimer's Disease, Healthy Adult Participants
- Keywords
- PET, MRI, Tau, SV2A, MAO-B, Synaptic density, Reactive astrogliosis, 18F-MK6240
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIM: to investigate the relationship between synaptic density, tau and reactive astrogliosis in Alzheimer's disease (AD) versus healthy controls and centenarians.
DESIGN: this cross-sectional study will recruit patients with biomarker-proven AD, age- and sex-matched healthy controls as well as centenarians. All subjects will undergo a neuropsychological evaluation and ultra-high-performance PET imaging sessions with 18F-SynVesT-1 (synaptic density), 18F-MK6240 (tau) and 18F-SMBT-1 (reactive astrogliosis) as well as structural and diffusion MRI. Blood samples will be taken for the evaluation of blood-based biomarkers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with AD | – | Other: 18F-SMBT-1 PET, Other: 18F-SynVesT-1 PET, Other: 18F-MK-6240 PET |
| Healthy control participants | – | Other: 18F-SMBT-1 PET, Other: 18F-SynVesT-1 PET, Other: 18F-MK-6240 PET |
| Centenarians | – | Other: 18F-SMBT-1 PET, Other: 18F-SynVesT-1 PET, Other: 18F-MK-6240 PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Alzheimer's disease will be recruited from the memory clinic of the University Hospitals Leuven (UZ Leuven). Centenarians will be recruited from the 100-plus study at UMC Amsterdam. Healthy controls will be recruited through internet advertisements.
Key inclusion criteria (10 listed)
- Patient has a clinical diagnosis of biomarker proven AD (prodromal AD or dementia due to AD).
- Patient has an mini-mental state examination (MMSE) score of 15 or higher.
- Patient or legal representative is able to understand the patient information brochure and give written informed consent.
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Participant is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.
Key exclusion criteria (20 listed)
- Patient has a history of any major other disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator.
- Patient is on anti-amyloid therapy.
- Patient has contra indications for magnetic resonance imaging (MRI).
- Patient is a current smoker.
- Patient is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-SMBT-1 PETUltra-high-performance positron emission tomography (PET) of monoamine oxidase B (MAO-B) using the radioligand 18F-SMBT-1 on the NeuroEXPLORER PET scanner. | Other | Centenarians, Healthy control participants, Patients with AD |
| 18F-SynVesT-1 PETUltra-high-performance positron emission tomography (PET) of synaptic vesicle glycoprotein 2A (SV2A, synaptic density) using the radioligand 18F-SynVesT-1 on the NeuroEXPLORER PET scanner. | Other | Centenarians, Healthy control participants, Patients with AD |
| 18F-MK-6240 PETUltra-high-performance positron emission tomography (PET) of tau neurofibrillary tangles using the radioligand 18F-MK6240 on the NeuroEXPLORER PET scanner. | Other | Centenarians, Healthy control participants, Patients with AD |
Primary outcome
The correlation between tau, synaptic density and reactive astrogliosis
Time frame: Baseline
Mediation and correlation analyses will be performed to investigate the correlation between tau, synaptic density and reactive astrogliosis PET measures as quantified by standardized uptake value ratios (SUVR).
Changes in synaptic density, tau and reactive astrolgiosis between AD patients, controls and centenarians
Time frame: Baseline
Synaptic density, tau and reactive astrolgiosis PET measures, as quantified by standardized uptake value ratios (SUVR), will be compared across the three different groups: patients with AD, healthy control participants and centenarians.
3 secondary outcomes
Correlation of synaptic density, tau and reactive astrogliosis with diffusion MRI
Time frame: Baseline
Correlation of synaptic density, tau and reactive astrogliosis with blood-based biomarkers
Time frame: Baseline
Correlation of synaptic density, tau and reactive astrogliosis with cognitive performance
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Healthy Adult Participants, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 10 inclusion and 20 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: opening soon, as of the sponsor's last update on 2 Nov 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 Belgium. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between tau, synaptic density and reactive astrogliosis (time frame: Baseline). 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?
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 2 Nov 2026.