Patients visiting the VUmc Alzheimer Center with objective cognitive complaints or diagnosed with Alzheimer's Disease.
Conditions
Sponsors
VU University medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject : - must be = 50 to = 85 years of age. - is seen at the memory clinic of the VUmc Alzheimer Center upon referral of another clinician and follows the routine screening procedure - must have results of routine clinical laboratory tests including a complete blood count (CBC) a physical examination, vital signs within normal limits or clinically acceptable to the investigator within 60 days prior to enrollment. - (or legal representative) must have signed (the study specific)informed consent form, which covers the scope and nature of this agreement before screening assessments. - (or legal representative) must have checked "Yes" to the following questions located on page 2 of the general informed consent form of the Alzheimer Center : o I give my consent for the storage and use of my coded medical information. o I give my consent for the collection, storage and provision of coded samples of my cerebrospinal fluid to the Alzheimer’s Center Biobank and the String of Pearls Initiative Parelsnoer Initiatief for the purposes outlined in the information. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patients who - are considered medically unstable; - require additional laboratory tests or workup between enrolment and completion of the PET scan; - have a clinically significant infectious disease, including Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection; - are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days prior to the PET scan; - have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ?-secretase or ?-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial; - have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the PET scan; - are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) or breast feeding at screening. Females must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of [18F]Flutemetamol; - are claustrophobic; - have abnormalities on MRI other than white matter changes or an incidental small lacunar lesion which may can affect Flutemetamol PET scan reading; - have donated blood within 3 months before the scan day;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the concordance of [18F]Flutemetamol PET across a range of detergent-based CSF tau:Abeta 1-42 ratio assay values across the range of AD pathology in controls, MCI subjects and AD patients. ;Secondary Objective: To compare the concordance between [18F]Flutemetamol PET and the detergent-based CSF assay and the well established abeta 1-42, tau and p-tau assays used routinely in VUmc in the same range of patients;Primary end point(s): The main outcome measures are the concordance (diagnostic agreement of reported brain amyloid status) between [18F]Flutemetamol PET and a range of CSF tau:abeta1-42 ratio values that meet independently-defined minimum criteria for a binary classifier of AD (sensitivity = 0.8, specificity >0.6). This range of CSF threshold values will be determined in a separate study currently underway, using additional independently collected CSF samples. Secondary outcome is the concordance between PET amyloid status and routine CSF abeta 1-42, total tau and p-tau 181 values. ;Timepoint(s) of evaluation of this end point: Evaluation will be executed after the last patient's last visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome is the concordance between PET amyloid status and routine CSF abeta 1-42, total tau and p-tau 181 values. ;Timepoint(s) of evaluation of this end point: Evaluation will be executed after the last patient's last visit | — |
Countries
Netherlands
Contacts
Public ContactAlzheimer Center
VU University medical center
Outcome results
None listed