Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein

Inclusion Criteria

• •Written informed consent must be obtained before any assessment is performed.
• •Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use two methods of contraception, one of which is a barrier method for the duration of the study.
• •Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
• •Male subjects must not donate sperm for the study duration.
• •Willing and able to cooperate with study procedures.
• •Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MK-6240 imaging visit.
• •No cognitive impairment from neuropsychological battery as judged by the investigator
• •Have screening \[18F\]Florbetapir PET imaging demonstrating no significant amyloid binding based on qualitative (visual read).
• •No family history of Alzheimer's disease or neurological disease associated with dementia
• •Have a CDR global score=0
• •Have an MMSE score ≥28
• •Willing and able to cooperate with study procedures.
• •Males and females aged 50 to 80 years.
• •Have probable Alzheimer's disease dementia, based on the NINCDS/ADRDA and DSM-IV criteria, with mild severity and amnestic presentation
• •Have a CDR score ≥ 0.5 at screening
• •Have a MMSE score between ≤26 .
• •Have screening \[18F\]Florbetapir or prior (in the last 12 months) amyloid PET imaging demonstrating amyloid binding based on qualitative (visual read).\[18F\]Florbetapir PET imaging results will be shared with participants and scans may be used by participants for future research use.
• •A brain MRI that supports a diagnosis of AD, with no evidence of significant neurologic pathology.
• •Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before screening visit.
• •Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
• •The subject has an appropriate caregiver capable of accompanying subject on all visits, if necessary.
• •Subjects must be active smokers at the time of initial consent