mild cognitive impairment:MCI frontotemporal dementia:FTD
Conditions
Interventions
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
Sponsors
University of Tsukuba Hospital
Shimadzu Corporation MCBI Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of brain blood flow by fNIRS | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTetsuaki ARAI
University of Tsukuba Department of Neuropsychiatry,Division of Clinical Medicine,Faculty of Medicine
Outcome results
None listed