The clinical prognostic value of amyloid imaging with [18F]AV-45 in a subjects with subjective complaints

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

- age >45
- Written informed consent
- Weight >50 kg , - Able to tolerate 70-minute scanning
- No objective cognitive impairment (i.e. no diagnosis of dementia, mild cognitive impairment, psychiatric or neurological disorder explaining cognitive complaints).
- MMSE ><= 18

Exclusion Criteria

Patients who
1. Have a current a major psychiatric disorder, such as psychosis, schizophrenia, severe personality disorder or depression with vital signs, abuse of alcohol or other substances. Or patients who have a neurological disorder, such as Parkinson's disease, symptomatic stroke, mental retardation.
2. Are women of childbearing potential who are not surgically sterile, not refraining
from sexual activity or not using reliable methods of contraception. Women of
childbearing potential must not be pregnant (negative urine *-hCG at the time of
screening and negative urine *-hCG on the day of imaging) or breast feeding at
screening. Women 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 florbetapir (18F);
3. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe
drug allergies should be determined by the Principal Investigator or Co-Principal
Investigator, and any questions about a subject*s eligibility can be directed to Avid
Radiopharmaceuticals Inc. If a subject has a history of severe drug allergies, it may be
dangerous for them to participate in a study with a novel compound);
4. 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 no investigational medication (yet) or only placebo during the course of the trial;
5. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior
to the study imaging session.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The outcome measure, amyloid deposition (both visual and quantitative ),<br /><br>acquired with [18F]AV-45 PET scans in a memory clinic patient cohort.<br /><br>Quantification is performed with optimized kinetic models acquired in another<br /><br>research Florbetapir protocol (kinetic modelling of 18 F labeled amyloid<br /><br>tracers). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are the concordance of [18F]AV-45 PET with MRI<br /><br>markers (MTA) and with CSF markers (A* 1-42, total tau and p-tau 181) will be<br /><br>assessed by binary rating (e.g. normal or abnormal) and amyloid tracer<br /><br>quantification for each of these measures. Furthermore, at baseline dementia<br /><br>severity and neuropsychological measures will be obtained to allow analysis of<br /><br>associations with continuous measures of cognitive impairment to determine the<br /><br>prognostic value of [18F]AV-45 PET.</p><br>