Unique ID issued by UMIN | UMIN000025053 |
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Receipt number | R000028702 |
Scientific Title | Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI). |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2018/12/01 10:16:42 |
Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI).
Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI).
Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI).
Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI).
Japan |
mild cognitive impairment:MCI
frontotemporal dementia:FTD
Psychiatry |
Others
NO
The purpose of this study is to develop the method objective measuring for cognitive decline in participant who have cognitive impairment and its improvement by measurement of cerebral blood flow using fNIRS.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Change of brain blood flow by fNIRS
MCI
1 Examination of cognitive
Magnetic resonance imaging
Single photon emission computed tomography
Mini mental state examination
Clinical dementia rating
Geriatric depression scale
Wecheler memory scale-reviced
2 Blood test
Measured data of peptide markers and its related proteins
FTD,NDC
1Examination of cognitive
Magnetic resonance imaging
Single photon emission computed tomography
Mini mental state examination
Clinical dementia rating
Geriatric depression scale
Frontal assessment battery
2 BPSD
Stereotypy Rating Inventory
Apathy evaluation scale
3 basic information
3-1 sex,age,height,weight,body composition,disease,joint pain medicine,education,depression,the years passed after diagnosis of dementia,family status,activities of daily living,quality of life
3-2 Zarit Care burden standard (J-ZBI _8)
Japanese Version of the Zarit Caregiver Burden Interview
3-3 performance tests
muscle strength (grip,lower muscle),balance,gait speed (usual gait speed,6 minutes walk test),flexibility,dexterity
3-4 endurance
Vo2max is evaluated using bicycle ergometer.
3-5 medicine
information from medicine log
3-6 Sleep condition
Actigraph
3-7 Physical activity
physical activity is assessed by 3-axis accelerometer (HJA-750C, OMRON)
3-8 biochemical examination
I direct it to refrain from the meals within 12 hours and collect blood in a hunger state. I perform the drawing blood before and after intervention.
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
6
Prevention
Device,equipment | Behavior,custom | Maneuver |
Interventions MCI
Training muscle strength
Intervention period 6 months
Control MCI
No treatment
Intervention period 6 months
Interventions FTD
Training bicycle ergometer
Intervention period 6 months
Control FTD
No treatment
Intervention period 6 months
Interventions NDC
Training bicycle ergometer
Intervention period 6 months
Control NDC
No treatment
Intervention period 6 months
50 | years-old | <= |
79 | years-old | >= |
Male and Female
Criteria for amnestic MCI
Type1 complaint of memory disturbance from the participant plus approval by the study partner
Type2 memory disturbance approved by the study partner, without the subjective complaint of the participant
MMSE 24-30
Scores of Wechsler memory Scale-R logical memory 2
corrected for education,
below the cut-off levels.
education 0-9 years 2 or lower
10-15 years 4 or lower
over 16 years 8 or lower
CDR 0.5 not depressed
Criteria for behavioural variant FTD
Criteria for Behavioral Variant FTD
Possible bvFTD
Three of the following behavioural cognitive symptoms A-F must be present to meet criteria.
A Early behavioural disinhibition
B Early apathy or inertia
C Early loss of sympathy or empathy
D Early perseverative,stereotyped or compulsive ritualistic behaviour
E Hyperorality and dietary changes
F Neuropsychological profile: executive/generation deficits with relative sparing of memory and visuospatial functions
Probable bvFTD
All of the following symptoms
A-C must be present to meet criteria.
A Meets criteria for possible bvFTD
B Exhibits significant functional decline
C Imaging results consistent with bvFTD
1Parkinson'disease, multiple cerebral infarction, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae
2Signs of brain infection, focal brain lesions(eg infarction)that may affect cognitive function.
3Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI
4Major depression or bipolar disorder within past 1 year, addiction to alcohol or other drugs within past 2 years, presence of fatal or unstable diseases, vitamin B12 or folate deficiency, syphilis, thyroid function abnormality
5Administration of psychoactive drugs (defined in procedure manual)
6Administration of warfarin
7Participant in clinical trial of new AD therapeutic drug
8Clinical Judgment Committee
9Participant with impaired ADL
60
1st name | |
Middle name | |
Last name | Tetsuaki ARAI |
University of Tsukuba
Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
029-853-3182
4632tetsu@md.tsukuba.ac.jp
1st name | |
Middle name | |
Last name | Tetsuaki ARAI |
University of Tsukuba
Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
029-853-3182
4632tetsu@md.tsukuba.ac.jp
University of Tsukuba Hospital
University of Tsukuba
Other
Shimadzu Corporation
MCBI Corporation
None
NO
筑波大学附属病院
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Terminated
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 11 | Month | 29 | Day |
2018 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028702
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