Validating in vivo quantification of tau with [18F]AV-1451 PET

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

Healthy volunteers:
1. At least 50 years of age;
2. Have no evidence of cognitive impairment as indicated by a cognitive neurologist;
3. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV1451 PET scan procedures.;MCI due to AD subjects:
1. At least 50 years of age;
2. Have a clinical diagnosis of MCI (Albert, 2011)
3. Have positive A* biomarkers on PET and/or CSF
4. Have a Mini Mental State Examination (MSSE) of 18 or higher;
5. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV1451 PET scan procedures.;AD patients:
1. At least 50 years of age;
2. Have a clinical diagnosis of probable AD (McKhann, 2011)
3. Have a Mini Mental State Examination (MMSE) of 18 or higher;
4. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV-1451 PET scan procedures.

Exclusion Criteria

1. Has contra indications for MRI scanning and therefore can not receive brain MRI
2. Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of a PET scan;
3. Has a history of severe traumatic brain injury (TBI);
4. Is a female of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception for up to 24 hours after scanning procedures. Females of childbearing potential must not be pregnant or breastfeeding at screening.
5. Has 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.);
6. Has ever participated in an experimental study with a tau or amyloid targeting agent, unless it can be documented that the subject received only placebo during the course of the trial.
7. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome is the test-retest variability of the previously defined<br /><br>simplified tracer kinetic model to quantify specific binding of [18F]AV-1451.</p><br>

Secondary Outcome Measures