(4R)-4-(3-(18F)FLUORANYL-5-FLUOROPHENYL)-1-[(3-METHYLPYRIDIN-4-YL)METHYL]PYRROLIDIN-2-ONE for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- At least 50 years of age\n- Biomarker evidence (CSF or PET) for the presence of Aβ pathology.\n- 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;\n- Signed informed consent for Amsterdam Dementia Cohort 2016.061);"}

Exclusion criteria

• {"criterion_text":"- Has contra indications for MRI scanning and therefore has and cannot receive brain MRI;\n- 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;\n- 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;\n- Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the Principal Investigator;\n- 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;\n- 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;\n- 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.\n- 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"}

Primary endpoints

• {"endpoint_text":"- Quantification of brain regional [18F]SynVesT-1 uptake (synaptic density) and regional [ 18F]flortaucipir uptake (tau)","definition_or_measurement_approach":"Quantification of regional tracer uptake as described (measurement of [18F]SynVesT-1 and [18F]flortaucipir uptake), i.e. regional uptake quantification as stated in the main objective."}

Secondary endpoints

• {"endpoint_text":"- association between [18F]Flortaucipir (tau) binding and [18F]SynVesT-1 (synaptic density) binding","definition_or_measurement_approach":"Assessment of the association between tracer binding measures (binding/uprake of [18F]Flortaucipir and [18F]SynVesT-1) as stated in the secondary objective."}

Netherlands

Earliest CTIS Part Ii Submission Date

29-11-2024

Latest Decision Or Authorization Date

10-12-2024

Processing Time Days

11

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands