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Clinical evaluation of PET probe [18F]SMBT-1

Clinical evaluation on usefulness and safety of a new PET probe [18F]SMBT-1 in Alzheimer's disease and Progressive supranuclear palsy - PETSMBT1ADPSP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021200019
Enrollment
24
Registered
2020-08-25
Start date
2020-09-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers disease (AD), Progressive Supranulcear Palsy (PSP) Alzheimers disease (AD), Progressive Supranulcear Palsy (PSP)

Interventions

1. Intravenous injection of radiopharmaceutial such as [18F]SMBT-1 in the right arm and scannning with PET scanner. 2. Insertion of an arterial chatheter into the radiial artery and serial arterial bl
injection of radiopharmaceutial, Insertion of arterial chatheter and serial blood sampling

Sponsors

Tashiro Manabu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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 (including severe ethanol sensitivity) (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 (including severe ethanol sensitivity) (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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 2) Correlations between [18F]SMBT-1 accumulation and general cognitive abilities and [11C]PiB. 3) Changes in vital signs (blood pressure, heart rate, SPO2) and blood tests (blood cell counts and blood chemistry)

Contacts

Public ContactKazuko Takeda

Research Center for Accelerator and Radioisotope Science, Tohoku University

driving@cyric.tohoku.ac.jp+81-22-795-7800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026