Alzheimer's disease dementia
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
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 Aβ 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 Aβ 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);
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the spatial distribution of specific [11C]SMW139 binding in patients with AD compared to age-matched cognitively unimpaired subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the association of (spatial) [11C]SMW139 specific binding to neuropsychological performance and neurodegeneration. | — |
Countries
Netherlands
Outcome results
None listed