Imaging inflammation in Alzheimer*s Disease

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

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

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.