This study has been transitioned to CTIS with ID 2024-517636-22-00 check the CTIS register for the current data. The main objective of the present study is to investigate the association between in vivo regional synaptic loss ([18F]SynVesT-1 PET),…
ID
Source
Brief title
Condition
- Structural brain disorders
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameters include the quantification of regional [18F]SynVesT-1 (synaptic
density) uptake and regional [18F]flortaucipir (tau) uptake. The main endpoint
includes the associations of (spatial) [18F]SynVesT-1 with regional
[18F]flortaucipir.
Secondary outcome
Secondary endpoints include the association of (spatial) [18F]SynVesT-1 and
[18F]flortaucipir to neuropsychological performance based on test scores.
Background summary
With the introduction of the positron emission tomography (PET) tracer
[18F]SynVesT-1, it is now possible to visualize and quantify in vivo synaptic
density in the human brain. Synapses are crucial for cognitive function, and
post-mortem studies have indicated synaptic loss as the closest pathological
correlate of cognitive decline in patients with mild cognitive impairment (MCI)
and Alzheimer*s Disease (AD) dementia In vivo imaging of synaptic loss and tau
pathology could provide novel insights in disease mechanisms underlying AD and
potentially new prognostic biomarkers. By concurrently investigating two AD
hallmarks, this study holds potential to investigate complex disease
mechanisms, which holds great importance for the development of therapeutic
targets.
Study objective
This study has been transitioned to CTIS with ID 2024-517636-22-00 check the CTIS register for the current data.
The main objective of the present study is to investigate the association
between in vivo regional synaptic loss ([18F]SynVesT-1 PET), in vivo regional
tau pathology ([18F]flortaucipir PET). Secondary objectives include to assess
the associations with cognition.
Study design
Cross-sectional study.
Study burden and risks
There is no individual benefit from the current study. Risks associated with
participation in this study are related to 1) radiation exposure, 2)
idiosyncratic reaction to the tracer, and 3) discomfort during scanning.
Results of the current study are deemed important as it could lead to a better
understanding of the disease mechanisms underlying development and progression
of cognitive decline in AD, and is therefore regarded by the researchers as
very meaningful.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- At least 50 years of age;
- Biomarker evidence (CSF or PET) for the presence of Aβ pathology.
- Subjects must, in the opinion of the principal investigator/attending
neurologist, be able to tolerate study procedures and be competent to make a
well-informed decision to participate in this study;
- Signed informed consent for Amsterdam Dementia Cohort 2016.061);
Exclusion criteria
- Has contra indications for MRI scanning and therefore has and cannot receive
brain MRI;
- Has evidence of structural abnormalities such as major stroke or mass on MRI
that is likely to interfere with the clinical presentation and/or
interpretation of PET scan;
- Is a woman of childbearing potential who is not surgically sterile, not
refraining from sexual activity or not using reliable methods for
contraception. Women of childbearing potential must orally confirm not to be
pregnant or breast feeding at screening;
- Has a relevant history of severe drug allergy or hypersensitivity. Relevant
severe drug allergies should be determined by the Principal Investigator;
- Has ever participated in an experimental study with a tau, amyloid or synapse
targeting agent, unless it can be documented that the subject received only
placebo during the course of the trial;
- Has been injected with a previously administered radiopharmaceutical within 6
terminal half-lives or when total yearly radiation exposure exceeds 11.3 mSv
for females and 15.3 mSv for males;
- History of any clinically significant cardiovascular, endocrinology,
hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary,
neurologic (with the exception of AD), psychiatric, renal or other major
disease, as determined by the principal investigator;
- Is a member of the study team, an employee of the department of Radiology
and Nuclear medicine or the department of Neurology of the Amsterdam UMC, or is
related to an employee of department of Radiology and Nuclear medicine or the
department of Neurology of the Amsterdam UMC.
- The following medications during the study and 4 weeks prior to
[18F]SynVesT-1 PET:
o Use of anticonvulsant medications;
o Other medications that, in the opinion of the Investigator, may interfere
with the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-517636-22-00 |
| EudraCT | EUCTR2020-002511-22-NL |
| CCMO | NL74184.029.21 |