Amyloid-beta positive individuals across the Alzheimer's disease continuum and amyloid-beta negative individuals without cognitive complaints
Conditions
Interventions
Product Name: [11C]SMW139
Pharmaceutical Form: Radiopharmaceutical precursor, solution
Sponsors
Amsterdam UMC VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1: subjects along the AD continuum In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Be along the AD continuum, defined as having positive biomarker evidence (CSF or PET) for the presence of Aß pathology. 2. At least 50 years of age; 3. 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; 4. Signed informed consent for Amsterdam Dementia Cohort (2016.061); Group 2: cognitively unimpaired subjects In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Have biomarker evidence (CSF or PET) for the absence of Aß pathology; 2. Have no objective cognitive impairment as determined by a neuropsychologist or neuropsychological testing; 3. At least 50 years of age; 4. 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. 5. Signed informed consent for Amsterdam Dementia Cohort (2016.061); Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Has contra indications for MRI scanning and therefore cannot receive a brain MRI; 2. Has evidence of (gross) structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan; 3. Inability to undergo PET-CT with administration of radioligand [11C]SMW139; 4. 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 not be pregnant or breast feeding at screening and at imaging; 5. Has a relevant history of severe drug allergy or hypersensitivity. This includes (but is not limited to) hay fever, allergies to cats and dogs, and dust mite allergy. Other relevant severe drug allergies or hypersensitivities should be evaluated by the Principal Investigator; 6. Has ever participated in an experimental study with a tau, amyloid or neuroinflammation targeting agent, unless it can be documented that the subject received only placebo during the course of the trial; 7. History of any clinically significant cardiovascular, endocrinology, hematologic, hepatobiliary, immunologic, inflammatory, metabolic, urologic, pulmonary (including asthma), neurologic (with the exception of AD), psychiatric, renal or other major disease, as determined by the principal investigator; 8. In male subjects Hb < 8.0 g/dL, in female subjects Hb < 7.0 g/dL; 9. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv; 10. Has a history of severe traumatic brain injury (TBI); 11. The following medications during the study and 4 weeks prior to [11C]SMW139 PET: a. Use of anticonvulsant medications; b. Anti-inflammatory medications (e.g. chronic NSAID use); c. Other medications that, in the opinion of the investigator, may interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the spatial distribution of [11C]SMW139 specific binding in (early) AD and age/sex-matched cognitively unimpaired subjects. ;Secondary Objective: Secondary objectives include associations of regional [11C]SMW139 uptake with cognitive measures and measures of neurodegeneration.;Primary end point(s): Quantitative assessment of [11C]SMW139 uptake;Timepoint(s) of evaluation of this end point: After all participants have completed the PET scanning. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Neuropsychological functioning and neurodegeneration;Timepoint(s) of evaluation of this end point: After all participants have completed their study visits. | — |
Countries
Netherlands
Contacts
Public Contactdept. Radiology & Nuclear Medicine
Amsterdam UMC VUmc
Outcome results
None listed