Study on usefulness of [18F]SMBT-1 in stratification of dementias
(SMBTSD)
Multicenter study on SMBT-1 (SMBTSD)
Tashiro Manabu
Tohoku University Hospital
Seiryo-cho 1-1, Aoba-ku, Sendai, Miyagi
+81-22-795-7797
manabu.tashiro.a2@tohoku.ac.jp
Takeda Kazuko
Research Center for Accelerator and Radioisotope Science, Tohoku University
Aoba 6-3, Aramaki, Aoba-ku, Sendai, Miyag i
+81-22-795-4438
driving@cyric.tohoku.ac.jp
Recruiting
Feb. 07, 2022
149
Interventional
non-randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
diagnostic purpose
Mild cognitive impairment (MCI) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 50 to 90 years old upon first examinations
(3) Those who are diagnosed as MCI based on Petersen's criteria
(4) Those who can tolerate relatively long PET examination (up to 45 min)
Alzheimer's disease (AD) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 50 to 90 years old upon first examinations
(3) Those who are diagnosed as AD
(4) Those who can tolerate relatively long PET examination (up to 45 min)
Progressive Supranulcear Palsy (PSP) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 50 to 90 years old upon first examinations
(3) Those who are diagnosed as PSP
(4) In principle, those who showed negative findings in amyloid PET
(*Some cases with amyloid findings could also be selected by decision of the prinripal investigator of each medical facility or hospital)
(5) Those who can tolerate relatively long PET examination (up to 45 min)
Frontotemporal lobar degeneration (FTLD) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 50 to 90 years old upon first examinations
(3) Those who are diagnosed as FTLD
(4) Those who showed negative findings in amyloid PET for screening
(*Some cases with amyloid findings could also be selected by decision by the prinripal investigator of each medical facility or hospital)
(5) Those who can tolerate relatively long PET examination (up to 45 min)
Dementia with Lewy bodies (DLB) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: 50 to 90 years old upon first examinations
(3) Those who are diagnosed as DLB, or those who fulfil the conditions of DLB with mild cognitive impairment. And those who diagnosed as PDD, in which Parkinsonism was observed earlier than dementia symptoms.
(4) Those who showed abnormal findings in MIBG cardiac scintigraphy or dopamine transporter SPECT
(5) Those who can tolerate relatively long PET examination (up to 45 min)
Healthy control (HC) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: basically 50 to 90 years old upon first examinations
(3) MMSE scores hig her than or equal to 24
(4) Wechsler memory Scale-R Log ical memory II scores hig her than cut-off (>3 for those who have e
ducation 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 can tolerate relatively long PET examination (up to 2 hours)
MCI, AD, PSP, FTLD, DLB groups
(1) Other neurological disorders (including cerebrovascular disorders, etc.), drug addicts, alcoholism, as
well as severe cardiavascular diseases
(2) Administration of irreversible MAO-B inhibitors
(3) Habitual smoking (within 1 year of entry)
(4) Being in the period of pregnancy, possible pregnancy, breast feeding, within 28 days after child birth
(5) Severe allergic reactions to drugs and foods (including severe ethanol sensitivity: in Tohoku area only)
(6) Psychiatric disorders, which may make the participation to this study difficult
(7) Taboo conditions for MRI examinations (cardiac pacemaker, intracorpoporial metals, etc. to be checked with questionnaire in advance)
(8) Systemic circulatory and metabolic disorders as well as organ dysfuctions, such as diabetes melitus, hypertension, endocrinolog ical disorders, congestive heart failure, angina petoris, severe renal dysfunctions with Ccr<30mL/min or under plasmapheresis)
(9) Past history of malignant diseases within 1 year of entry (*Early cancer patients with "minimal" effects due to therapeutic interventions, as confirmed by the responsible doctor, can be exceptionally included to the current study.)
(10) Any sociomedial conditions, which may make the participation to this study difficult
HC group
(1) Any neurolog ical disorders
(2) drug addicts including alcoholism
(3) Habitual smoking (within 1 year of entry)
(4) Being in the period of pregnancy, possible pregnancy, breast feeding, within 28 days after child birth
(5) Severe allergic reactions to drugs and foods (including severe ethanol sensitivity: in Tohoku area only)
(6) Psychiatric disorders, which may make the participation to this study difficult
(7) Taboo conditions for MRI examinations (cardiac pacemaker, intracorpoporial metals, etc. to be checked with questionnaire in advance)
(8) Systemic circulatory and metabolic disorders as well as organ dysfuctions, such as diabetes melitus, hypertension, endocrinolog ical disorders, congestive heart failure, angina petoris, severe renal dysfunctions with Ccr<30mL/min or under plasmapheresis)
(9) Past history of malignant diseases within 1 year of entry (*Early cancer patients with "minimal" effects due to therapeutic interventions, as confirmed by the responsible doctor, can be exceptionally included to the current study.)
(10) Any sociomedial conditions, which may make the participation to this study difficult
50age old over
90age old under
Both
MCI, AD, FTLD, PSP, DLB
1. Intravenous injection of a new radiopharmaceutial [18F]SMBT-1 and scannning with PET scanner.
2. Intravenous injection of a radiopharmaceutial ([11C]PiB or [18F]flutemetamol) and scannning with PET scanner.
Primary Outcome 1:
1a) Comparison of Standardized uptake values (SUVs) and SUV ratios (SUVRs) between clinical categories (HC, MCI, AD) of AD continuum (transverse study), as well as the locations and statstical values of statistically significant findings in voxel-by-voxel analysis.
1b) Comparison of Standardized uptake values (SUVs) and SUV ratios (SUVRs) between different clinical categories (FTLD, DLB, PSP, HC, MCI, AD, HC) (transverse study), as well as the locations and statstical values of statistically significant findings in voxel-by-voxel analysis.
Primary Outcome 2:
2a) Comparison of Standardized uptake values (SUVs) and SUV ratios (SUVRs) between 1st and following [18F]SMBT-1 PET images in HC, MCI, AD, FTLD, DLB, PSP in a longitudinal study design, as well as the locations and statstical values of statistically significant findings in voxel-by-voxel analysis.
2b) Correlation of Standardized uptake values (SUVs) and SUV ratios (SUVRs) of 1st [18F]SMBT-1 PET images of HC, MCI, AD, FTLD, DLB, PSP to other clinical findings (clinical symptoms, neuropsychological examinations and amyloid PET) especially those at the 2nd examination and to the changes between 1st and following examinations.
Secondary Outcome 1:
Correlations between [18F]SMBT-1 accumulation in 1st PET and other clinical information such as cognitive abilities, clinical symptoms, and findings of amyloid and tau PET investigations at 1st [18F]SMBT-1 PET examination.
Secondary Outcome 2:
Correlations between [18F]SMBT-1 accumulation in 2nd and following PET examinations and clinical information such as cognitive abilities, clinical symptoms, and findings of amyloid and tau PET investigations at 2nd and following [18F]SMBT-1 PET examinations.
AMED
JSPS
Tokyo Metropolitan Geriatric Medical Center Clinical Research Review Board
