Synaptic density and tau pathology in Alzheimer’s disease
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC Stichting
- Trial code
- EU 2024-517636-22-00
- Record updated
- 2024. december 10.
- Original description
Aim to quantify brain regional [18F]SynVesT-1 uptake (synaptic density) and [18F]flortaucipir uptake and their associationRead full original descriptionShow less
Synaptic density and tau pathology in Alzheimer’s disease (SYNAPSE)
Aim to quantify brain regional [18F]SynVesT-1 uptake (synaptic density) and [18F]flortaucipir uptake and their association
Inclusion: At least 50 years of age; - Biomarker evidence (CSF or PET) for the presence of Aβ pathology. - Subjects must, in the opinion of the 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: 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; - 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; - 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. - 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.