Alzheimer DiseaseNCT05384353
In Vivo PET of Synaptic Density in Cognitive Disorders
An observational study of Alzheimer Disease and Frontotemporal Degeneration, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study will compare the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders (Alzheimer's disease, Frontotemporal degeneration, dementia with Lewy bodies and late-life psychiatric disorders). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Frontotemporal Degeneration, Dementia With Lewy Bodies
- What is being tested?
- [18F]-SynVesT-1
- How many people
- 134 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Apr 2022to 4 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 40 healthy controls and 110 patients with uncertain diagnosis of cognitive impairment. All groups should include both sexes. Healthy controls should be evenly spread between the ages of 18 until 85.
Who may be able to join
- Age between 18 and 85 years old (aimed to be evenly spread over age intervals).
- Subject 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 and neuropsychological assessment.
- In subjects < 60 years of age, an unremarkable structural MRI scan as assessed by expert radiologist. In subjects >= 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) score <= 2 (of 3) on the Age-Related White Matter changes scale are acceptable.
- When older than 50 years of age, subject is willing to undergo an additional 18F-NAV-4694 scan when cerebral amyloid status is unknown.
- Patients referred with uncertain diagnosis and subsequent need for FDG PET brain in their work- up to differentiate between dementing disorders or to exclude dementia in late-onset psychiatric disorders with cognitive impairment.
- A routine neuropsychological assessment has been performed during clinical work-up in the memory clinic.
- Subject is at least 30 years old.
Who cannot join
- Subject 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 liver and kidney disease, uncontrolled diabetes or most forms of cancer).
- Subject has any history of a major neurological disorder or known cerebral structural abnormalities.
- Subject is first-degree relative (sibling, parent or children) of a person with neurological or psychiatric history assessed by a neurologist or psychiatrist (in particular dementia).
- Evidence of cognitive impairment as assessed by a MMSE score < 28.
- Subject has a history or evidence of psychiatric disease, as assessed by a validated psychiatric symptom self-assessment tool (Symptom Checklist-90, Beck Depression Inventory (BDI) and Geriatric Depression Scale (GDS)).
- Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
Show all 34Show fewer
- Subject chronically uses medication that has central nervous system effects (e.g., opioids, neuroleptics, sedatives, anti-depressants, sleep medication).
- 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 approximately 90 minutes inside the scanner.
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.
- Subject 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 pregnant (according to Ulti Med hCG urine test) or breastfeeding.
- Subject is a woman of childbearing potential (WOCBP) who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP: contraception methods with a relatively high Pearl index (natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active) are not accepted.
- Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.
- Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him/herself.
- Subject is on anticoagulant therapy.
- Patients:
- Subject has a history or evidence of other major neurological, major psychiatric or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, hematological, gastro-intestinal disorders or most forms of cancer).
- Subject's neurological condition has a predominant impact on motor function.
- Subject has no objective cognitive-behavioral deficit based on neuropsychological assessment.
- Subject has important vascular changes abnormal for age or other structural lesions on MR.
- Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
- 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 30 minutes inside the scanner.
- Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.
- Subject does not understand the study procedures or does not have a guardian who understands the study procedures.
- Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
- Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him/herself.
- Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.
- Subject is a woman of childbearing potential (WOCBP) who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP: contraception methods with a relatively high Pearl index (natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active) are not accepted.
- Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo PET of Synaptic Density in Cognitive Disorders: Prospective Evaluation of Neuronal Dysfunction and Relation to Symptomatology
This study will compare the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders (Alzheimer's disease, Frontotemporal degeneration, dementia with Lewy bodies and late-life psychiatric disorders). Moreover, changes in [18F]-SynVesT-1 PET will be evaluated as well as their correlation with specific symptomatology.
Read the detailed description
Forty healthy controls will be included as well as 110 patients that were referred by the UZ Leuven memory clinic with uncertain diagnosis of cognitive impairment and are already sent for [18F]-FDG PET imaging in their workup (estimated subgroup size: 30 patients with final diagnosis AD (aMCI); 20 patients with DLB; 30 patients with FTD; 30 patients with late-life psychiatric disorder).
Scans will be acquired on a 3T GE Signa PET-MR scanner, for 90 minutes starting at injection of 150 MBq [18F]-SynVesT-1 for healthy controls, and from 60 to 90 minutes post injection of 150 MBq [18F]-SynVesT-1 for patients. For healthy controls, discrete arterial blood samples will be manually collected every 10s from 10 to 90s; every 15s from 90s to 3min; and then at 3.5, 5, 6.5, 8, 12, 15, 20, 25, 30, 45, 60, 75 and 90min. Plasma samples for correction of radiometabolites will be collected at 3, 8, 15, 30, 60 and 90min after injection.
All healthy controls will also be subjected to a neuropsychological test battery and if necessary, additional limited neuropsychological testing on top of those from the memory clinic will be carried out in patients.
- Conditions
- Alzheimer Disease, Frontotemporal Degeneration, Dementia With Lewy Bodies, Psychiatric Disorder
- Being tested
- [18F]-SynVesT-1
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-SynVesT-1Other
PET radioligand binding to synaptic vesicle protein 2A as a proxy for synaptic density
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Synaptic density PET-MR and neuropsychological testing Receives: Other: [18F]-SynVesT-1 | |
| Patients with Alzheimer's disease | Synaptic density PET-MR and additional neuropsychological testing (if necessary) Receives: Other: [18F]-SynVesT-1 | |
| Patients with Frontotemporal degeneration | Synaptic density PET-MR and additional neuropsychological testing (if necessary) Receives: Other: [18F]-SynVesT-1 | |
| Patients with Dementia with Lewy Bodies | Synaptic density PET-MR and additional neuropsychological testing (if necessary) Receives: Other: [18F]-SynVesT-1 | |
| Patients with late-life psychiatric disorders | Synaptic density PET-MR and additional neuropsychological testing (if necessary) Receives: Other: [18F]-SynVesT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders
Anonymized [18F]-SynVest-1 and [18F]-FDG PET scans from patients with Alzheimer's disease, Frontotemporal degeneration, Dementia with Lewy Bodies or late-life pyschiatric disorders will be evaluated by expert raters blinded to the final diagnosis in order to compare the discriminative power of both tracers.
Measured: Patients will be included after they underwent [18F]-FDG PET. Estimated time between [18F]-SynVest-1 and [18F]-FDG PET is about 3 months. Estimated visit length for [18F]-SynVest-1 PET is 3 hours. Data analysis will be done when all subjects are scanned.
Synaptic density changes
[18F]-SynVesT-1 synaptic density changes in different cognitive disorders and correlation with symptomatology
Measured: Neuropsychological evaluation will be performed on the day of the [18F]-SynVesT-1 PET. Estimated visit length is 3 hours. Data analysis will be done when all subjects are scanned.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start11 Apr 2022
- Primary completion28 May 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen Van Laere, MD, PhD, DSc, Principal investigator, UZ/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384353
- Sponsor's protocol ID
- S66111
- Other IDs
- 2021-006610-36
- Status last verified
- Mar 2025
- First submitted
- 6 Apr 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carron C, Noe S, Vanderlinden G, Koole M, Schramm G, Van Laere K. Effects of motion and white matter hyperintensities on reference region based (1)(8)F-SynVesT-1 PET quantification in Alzheimer's disease and healthy volunteers. EJNMMI Res. 2026 Aug 3;16(1):153. doi: 10.1186/s13550-026-01496-8.
PubMed 42957873Vanderlinden G, Carron C, Van Opstal J, Cohilis M, Vandenberghe W, Koole M, Van Laere K. Quantification of 18F-SynVesT-1 binding in healthy ageing and head-to-head comparison with 11C-UCB-J. J Cereb Blood Flow Metab. 2026 Jun 1:271678X261454164. doi: 10.1177/0271678X261454164. Online ahead of print.
PubMed 42219995Vanderlinden G, Carron C, Vandenberghe R, Vandenbulcke M, Van Laere K. In vivo PET of synaptic density as potential diagnostic marker for cognitive disorders: prospective comparison with current imaging markers for neuronal dysfunction and relation to symptomatology - study protocol. BMC Med Imaging. 2024 Feb 12;24(1):41. doi: 10.1186/s12880-024-01224-5.
PubMed 38347458
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo PET of Synaptic Density in Cognitive Disorders: Prospective Evaluation of Neuronal Dysfunction and Relation to Symptomatology
- ClinicalTrials.gov ID
- NCT05384353
- Acronym / sponsor ID
- S66111
- Conditions
- Alzheimer Disease, Frontotemporal Degeneration, Dementia With Lewy Bodies, Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 20 May 2022 (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.
This study will compare the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders (Alzheimer's disease, Frontotemporal degeneration, dementia with Lewy bodies and late-life psychiatric disorders). Moreover, changes in [18F]-SynVesT-1 PET will be evaluated as well as their correlation with specific symptomatology.
Detailed description
Forty healthy controls will be included as well as 110 patients that were referred by the UZ Leuven memory clinic with uncertain diagnosis of cognitive impairment and are already sent for [18F]-FDG PET imaging in their workup (estimated subgroup size: 30 patients with final diagnosis AD (aMCI); 20 patients with DLB; 30 patients with FTD; 30 patients with late-life psychiatric disorder).
Scans will be acquired on a 3T GE Signa PET-MR scanner, for 90 minutes starting at injection of 150 MBq [18F]-SynVesT-1 for healthy controls, and from 60 to 90 minutes post injection of 150 MBq [18F]-SynVesT-1 for patients. For healthy controls, discrete arterial blood samples will be manually collected every 10s from 10 to 90s; every 15s from 90s to 3min; and then at 3.5, 5, 6.5, 8, 12, 15, 20, 25, 30, 45, 60, 75 and 90min. Plasma samples for correction of radiometabolites will be collected at 3, 8, 15, 30, 60 and 90min after injection.
All healthy controls will also be subjected to a neuropsychological test battery and if necessary, additional limited neuropsychological testing on top of those from the memory clinic will be carried out in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: [18F]-SynVesT-1Synaptic density PET-MR and neuropsychological testing |
| Patients with Alzheimer's disease | – | Other: [18F]-SynVesT-1Synaptic density PET-MR and additional neuropsychological testing (if necessary) |
| Patients with Frontotemporal degeneration | – | Other: [18F]-SynVesT-1Synaptic density PET-MR and additional neuropsychological testing (if necessary) |
| Patients with Dementia with Lewy Bodies | – | Other: [18F]-SynVesT-1Synaptic density PET-MR and additional neuropsychological testing (if necessary) |
| Patients with late-life psychiatric disorders | – | Other: [18F]-SynVesT-1Synaptic density PET-MR and additional neuropsychological testing (if necessary) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 healthy controls and 110 patients with uncertain diagnosis of cognitive impairment. All groups should include both sexes. Healthy controls should be evenly spread between the ages of 18 until 85.
Key inclusion criteria (8 listed)
- Patients referred with uncertain diagnosis and subsequent need for FDG PET brain in their work- up to differentiate between dementing disorders or to exclude dementia in late-onset psychiatric disorders with cognitive impairment.
- A routine neuropsychological assessment has been performed during clinical work-up in the memory clinic.
- Subject is at least 30 years old.
Key exclusion criteria (34 listed)
- Patients:
- Subject has a history or evidence of other major neurological, major psychiatric or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, hematological, gastro-intestinal disorders or most forms of cancer).
- Subject's neurological condition has a predominant impact on motor function.
- Subject has no objective cognitive-behavioral deficit based on neuropsychological assessment.
- Subject has important vascular changes abnormal for age or other structural lesions on MR.
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]-SynVesT-1PET radioligand binding to synaptic vesicle protein 2A as a proxy for synaptic density | Other | Healthy controls, Patients with Alzheimer's disease, Patients with Dementia with Lewy Bodies, Patients with Frontotemporal degeneration, Patients with late-life psychiatric disorders |
Primary outcome
Comparison of the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders
Time frame: Patients will be included after they underwent [18F]-FDG PET. Estimated time between [18F]-SynVest-1 and [18F]-FDG PET is about 3 months. Estimated visit length for [18F]-SynVest-1 PET is 3 hours. Data analysis will be done when all subjects are scanned.
Anonymized [18F]-SynVest-1 and [18F]-FDG PET scans from patients with Alzheimer's disease, Frontotemporal degeneration, Dementia with Lewy Bodies or late-life pyschiatric disorders will be evaluated by expert raters blinded to the final diagnosis in order to compare the discriminative power of both tracers.
Synaptic density changes
Time frame: Neuropsychological evaluation will be performed on the day of the [18F]-SynVesT-1 PET. Estimated visit length is 3 hours. Data analysis will be done when all subjects are scanned.
[18F]-SynVesT-1 synaptic density changes in different cognitive disorders and correlation with symptomatology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 42957873Carron C, Noe S, Vanderlinden G, Koole M, Schramm G, Van Laere K. Effects of motion and white matter hyperintensities on reference region based (1)(8)F-SynVesT-1 PET quantification in Alzheimer's disease and healthy volunteers. EJNMMI Res. 2026 Aug 3;16(1):153. doi: 10.1186/s13550-026-01496-8.
- Derived from this study: PubMed 42219995Vanderlinden G, Carron C, Van Opstal J, Cohilis M, Vandenberghe W, Koole M, Van Laere K. Quantification of 18F-SynVesT-1 binding in healthy ageing and head-to-head comparison with 11C-UCB-J. J Cereb Blood Flow Metab. 2026 Jun 1:271678X261454164. doi: 10.1177/0271678X261454164. Online ahead of print.
- Derived from this study: PubMed 38347458Vanderlinden G, Carron C, Vandenberghe R, Vandenbulcke M, Van Laere K. In vivo PET of synaptic density as potential diagnostic marker for cognitive disorders: prospective comparison with current imaging markers for neuronal dysfunction and relation to symptomatology - study protocol. BMC Med Imaging. 2024 Feb 12;24(1):41. doi: 10.1186/s12880-024-01224-5.
- 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. This study is not recruiting at the moment.
Koen Van Laere, MD, PhD, DSc principal investigator
UZ/KU Leuven
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 Disease and Frontotemporal Degeneration, 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 8 inclusion and 34 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: finished, as of the sponsor's last update on 8 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the discriminative power of [18F]-SynVesT-1 PET and the standard-of-care [18F]-FDG PET in different cognitive disorders (time frame: Patients will be included after they underwent [18F]-FDG PET. Estimated time between [18F]-SynVest-1 and [18F]-FDG PET is about 3 months. Estimated visit length for [18F]-SynVest-1 PET is 3 hours. Data analysis will be done when all subjects are scanned.). 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 NCT05384353, which also lists 3 linked publications.
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 8 Jan 2026.