Clinical evaluation of PET probe [18F]SMBT-1
- Conditions
- Alzheimer's disease (AD), Progressive Supranulcear Palsy (PSP)
- Registration Number
- JPRN-jRCTs021200019
- Lead Sponsor
- Tashiro Manabu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Alzheimer's disease (AD) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 60 to 85 years old
(3) Alzheimer's disease (AD), Progressive Supranulcear Palsy (PSP), Aged normal control (AN)
(4) Those who were judged positive in [11C]PiB PET for screening
(5) Those who can tolerate relatively long PET examination (up to 2 hours)
Progressive Supranulcear Palsy (PSP) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 60 to 85 years old
(3) Alzheimer's disease (AD), Progressive Supranulcear Palsy (PSP), Aged normal control (AN)
(4) Those who were judged negative in [11C]PiB PET for screening
(5) Those who can tolerate relatively long PET examination (up to 2 hours)
Aged control (AC) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: basically 60 to 85 years old (If not available, 40 to 60 can be also acceptable)
(3) MMSE scores higher than 24
(4) Wechsler memory Scale-R Logical memory II scores higher than cut-off (>3 for those who have education period of 0-7 years; >5 for education period of 8-15 years; >9 for education period of more than 16 years
(5) Those who were judged negative in [11C]PiB PET for screening
(6) Those who can tolerate relatively long PET examination (up to 2 hours)
AD group and PSP group
(1) Other neurological disorders (including cerebrovascular disorders), drug addicts, alcoholism, as well as severe cardiavascular diseases
(2) Administration of irreversible MAO-B inhibitors
(3) Habitual smoking (including those who have smoked within 1 year)
(4) Severe allergic reactions to drugs and foods
(5) Psychiatric disorders, which may make the participation to this study difficult
(6) Taboo conditions for MRI examinations (cardiac pacemaker, intracorpoporial metals, etc. to be checked with questionnaire in advance)
(7) Systemic circulatory and metabolic disorders as well as organ dysfuctions, such as diabetes melitus, hypertension, endocrinological disorders, congestive heart failure, angina petoris, severe renal dysfunctions with Ccr<30mL/min or under plasmapheresis)
(8) Being diagnosed or treated for malignant diseases within 1 year
(9) Any sociomedial conditions, which may make the participation to this study difficult
AN group
(1) Any neurological disorders
(2) drug addicts including alcoholism
(3) Habitual smoking (including those who have smoked within 1 year)
(4) Severe allergic reactions to drugs and foods
(5) Psychiatric disorders, which may make the participation to this study difficult
(6) Taboo conditions for MRI examinations (cardiac pacemaker, intracorpoporial metals, etc. to be checked with questionnaire in advance)
(7) Systemic circulatory and metabolic disorders as well as organ dysfuctions, such as diabetes melitus, hypertension, endocrinological disorders, congestive heart failure, angina petoris, severe renal dysfunctions with Ccr<30mL/min or under plasmapheresis)
(8) Being diagnosed or treated for malignant diseases within 1 year
(9) Any sociomedial conditions, which may make the participation to this study difficult
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuumulation of [18F]SMBT-1 in the brain regions of AD and PSP patients as well as in ACs such as standardized uptake value (SUV), as well as pharmacokinetic parameters such as K1, k2, k3, k4, binding potential and distribution volume.
- Secondary Outcome Measures
Name Time Method 1) Sensitivity and specificity to discriminate AD and PSP patients goups from ACs within this study. Correlations of brain [18F]SMBT-1 accumulation to the cognitive abilities of AD and PSP patients.<br>2) Correlations between [18F]SMBT-1 accumulation and general cognitive abilities and [11C]PiB.<br>3) Changes in vital signs (blood pressure, heart rate, SPO2) and blood tests (blood cell counts and blood chemistry)