Alzheimers disease dementia
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints include the association of (spatial) [18F]SynVesT-1 and [18F]flortaucipir to neuropsychological performance based on test scores. | — |
Countries
Netherlands
Outcome results
None listed