UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI).
Title of the study (Brief title)	Development of measuring method to monitor progression of cognitive decline and its improvement by intervention in dementia and mild cognitive impairment (MCI).
Region	Japan

Condition
Condition	mild cognitive impairment:MCI frontotemporal dementia:FTD
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of brain blood flow by fNIRS
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom Maneuver
Interventions/Control_1	Interventions MCI Training muscle strength Intervention period 6 months
Interventions/Control_2	Control MCI No treatment Intervention period 6 months
Interventions/Control_3	Interventions FTD Training bicycle ergometer Intervention period 6 months
Interventions/Control_4	Control FTD No treatment Intervention period 6 months
Interventions/Control_5	Interventions NDC Training bicycle ergometer Intervention period 6 months
Interventions/Control_6	Control NDC No treatment Intervention period 6 months
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	60

Research contact person
Name of lead principal investigator	Tetsuaki ARAI
Organization	University of Tsukuba
Division name	Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Address	1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
TEL	029-853-3182
Email	4632tetsu@md.tsukuba.ac.jp

Public contact
Name of contact person	Tetsuaki ARAI
Organization	University of Tsukuba
Division name	Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Address	1-1-1Tennoudai,Tsukuba,Ibaraki,Japan
TEL	029-853-3182
Homepage URL
Email	4632tetsu@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shimadzu Corporation MCBI Corporation
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	筑波大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 29 Day
Last modified on	2018 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028702