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Not yet recruitingNCT07906054Updated Nov 2, 2026

Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease

An observational study in Alzheimer's Disease and Healthy Adult Participants, sponsored by Universitaire Ziekenhuizen KU Leuven. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Updated Nov 2, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Alzheimer's Disease
  • Healthy Adult Participants

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Keywords

  • PET
  • MRI
  • Tau
  • SV2A
  • MAO-B
  • Synaptic density
  • Reactive astrogliosis
  • 18F-MK6240
  • 18F-SynVesT-1
  • 18F-SMBT-1
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 70 is below the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

- Patients with Alzheimer's disease (AD)

Inclusion Criteria:

  • Patient has a clinical diagnosis of biomarker proven AD (prodromal AD or dementia due to AD).
  • Patient has an (MMSE) score of 15 or higher.
  • Patient or legal representative is able to understand the patient information brochure and give written .

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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)).
  • 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

Exclusion Criteria:

  • 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 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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • Other18F-SMBT-1 PET

    Ultra-high-performance positron emission tomography (PET) of monoamine oxidase B (MAO-B) using the radioligand 18F-SMBT-1 on the NeuroEXPLORER PET scanner.

  • Other18F-SynVesT-1 PET

    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.

  • Other18F-MK-6240 PET

    Ultra-high-performance positron emission tomography (PET) of tau neurofibrillary tangles using the radioligand 18F-MK6240 on the NeuroEXPLORER PET scanner.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedRelationshipThe correlation between tau, synaptic density and reactive astrogliosisTime frame: Baseline
Nov 2, 2026
Secondary outcomes
3 edited
What changed in the outcomes
  • EditedRelationshipCorrelation of synaptic density, tau and reactive astrogliosis with diffusion MRITime frame: Baseline
  • EditedRelationshipCorrelation of synaptic density, tau and reactive astrogliosis with blood-based biomarkersTime frame: Baseline
  • EditedRelationshipCorrelation of synaptic density, tau and reactive astrogliosis with cognitive performanceTime frame: Baseline
Nov 2, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 2, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedRelationshipThe correlation between tau, synaptic density and reactive astrogliosisTime frame: Baseline
    Secondary outcomes 3 edited
    What changed in the outcomes
    • EditedRelationshipCorrelation of synaptic density, tau and reactive astrogliosis with diffusion MRITime frame: Baseline
    • EditedRelationshipCorrelation of synaptic density, tau and reactive astrogliosis with blood-based biomarkersTime frame: Baseline
    • EditedRelationshipCorrelation of synaptic density, tau and reactive astrogliosis with cognitive performanceTime frame: Baseline
  2. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07906054
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Oct 30, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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