Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies

Exclusion Criteria

• •Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 1 month before the \[18F\]MNI-815 imaging visit.
• •The subject has an appropriate caregiver capable of accompanying subject on all visits.
• •Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
• •Frontotemporal Dementia subjects:
• •Has a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia criteria (Neary, et al 1998)
• •Has a FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
• •Medications taken for symptomatic treatment of cognitive dysfunction must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
• •The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
• •Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
• •Modified Hachinski Ischemia Scale score of ≤ 4.
• •Progressive Supranuclear Palsy subjects:
• •Has a clinical diagnosis of PSP based the NINDS and Society for PSP criteria (Litvan, et al 1996)
• •Has FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
• •Medications taken for treatment of PSP symptoms must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
• •The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
• •Signed and dated written informed consent obtained from the subject and, when applicable the subject's legally authorized representative or caregiver.
• •Modified Hachinski Ischemia Scale score of ≤ 4.
• •Corticobasal Syndrome Subjects:
• •Has a clinical diagnosis of CBS based on consensus criteria for possible or probable corticobasal degeneration (Armstrong et al, 2013)
• •Has a FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
• •Medications taken for treatment of CBS symptoms must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
• •The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
• •Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
• •Modified Hachinski Ischemia Scale score of ≤ 4.
• •For all subjects
• •Current or prior history of any alcohol or drug abuse.
• •Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
• •Prior participation in other research protocols or clinical care in the last year such that radiation exposure is \>15 mSv and would exceed the annual limits.
• •Pregnancy or breastfeeding.
• •Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
• •Unsuitable veins for repeated venipuncture.
• •Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
• •Has received treatment that targeted amyloid-beta or tau within the last 24 months.
• •Has a FBB PET imaging demonstrating no evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.
• •Has FBB PET imaging with evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.
• •Has received treatment that targeted tau within the last 24 months.
• •Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits including: Specifically:
• •A diagnosis of idiopathic Parkinson's disease or Lewy body dementia and/or have a prominent and sustained response to levodopa therapy;
• •History of repeated strokes with stepwise progression of parkinsonian features or history of major stroke
• •FTD subjects:
• •Has FBB PET imaging with evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.
• •Has received treatment that targeted tau within the last 24 months.
• •Healthy subjects:
• •Has FBB PET imaging with evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.