In Vivo PET of Synaptic Density in Cognitive Disorders

NCT05384353 | Completed

• 2 other identifiers: S661112021-006610-36
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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). Moreover, changes in \[18F\]-SynVesT-1 PET will be evaluated as well as their correlation with specific symptomatology.

Conditions

Alzheimer Disease; Frontotemporal Degeneration; Dementia With Lewy Bodies; Psychiatric Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

Study Arms (5)

Healthy controls

Synaptic density PET-MR and neuropsychological testing

Other: [18F]-SynVesT-1

Patients with Alzheimer's disease

Synaptic density PET-MR and additional neuropsychological testing (if necessary)

Other: [18F]-SynVesT-1

Patients with Frontotemporal degeneration

Synaptic density PET-MR and additional neuropsychological testing (if necessary)

Other: [18F]-SynVesT-1

Patients with Dementia with Lewy Bodies

Synaptic density PET-MR and additional neuropsychological testing (if necessary)

Other: [18F]-SynVesT-1

Patients with late-life psychiatric disorders

Synaptic density PET-MR and additional neuropsychological testing (if necessary)

Other: [18F]-SynVesT-1

Interventions

[18F]-SynVesT-1 OTHER

PET radioligand binding to synaptic vesicle protein 2A as a proxy for synaptic density

Healthy controls; Patients with Alzheimer's disease; Patients with Dementia with Lewy Bodies; Patients with Frontotemporal degeneration; Patients with late-life psychiatric disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Vanderlinden 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.

  PMID: 38347458 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Mental Disorders

Interventions

SynVesT-1

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Koen Van Laere, MD, PhD, DSc

  UZ/KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 20, 2022
• Study Start: April 11, 2022
• Primary Completion: May 28, 2025
• Study Completion: June 4, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-03

Locations

BE (1)