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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014098
Receipt No. R000016388
Scientific Title Clinical study for degenerative dementia
Date of disclosure of the study information 2014/06/01
Last modified on 2016/12/23

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Basic information
Public title Clinical study for degenerative dementia
Acronym Degenerative dementia clinical study
Scientific Title Clinical study for degenerative dementia
Scientific Title:Acronym Degenerative dementia clinical study
Region
Japan

Condition
Condition Corticobasal syndrome, Primary progressive aphasia, Dementia with Lewy bodies
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Approximately, 20 % of patients with corticobasal syndrome, primary progressive aphasia, and dementia with Lewy bodies show Alzheimer's disease (AD) pathology. In this study, we aim to establish the diagnostic methods to differentiate patients with AD from non-AD pathology.
Basic objectives2 Others
Basic objectives -Others To establish the method of differential diagnosis using neuroimaging and neurospychological tests.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Dopamine transporter scan
Key secondary outcomes Neurospychological battery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Neuropshychological tests and Dopamine transporter scan
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1. corticobasal syndrome (CBS,J Neurol Neurosurg Psychiatry. 2012;83(4):405)
1. Mandatory criteria
1-1 Insidious onset and gradual progression
1-2 No sustained response to levodopa treatment
2. Major and minor criteria
2-1 Motor features
Akinetic rigid syndrome
Focal or segmental myoclonus
Asymmetrical dystonia
2-2 Cortical motor sensory features
Limb apraxia
Alien limb phenomenon
Cortical sensory loss or dyscalculia
2-3 Cognitive features
Speech and language impairment
Frontal executive dysfunction
Visuospatial deficits

2. Dementia with Lewy bodies (DLB, Neurology 2005;65;1863)
1. Central feature
Dementia defined as progressive cognitive decline of sufficient magnitude to interfere with normal social or occupational function.
Deficits on tests of attention, executive function, and visuospatial ability may be especially prominent.
2. Core features (two core features are sufficient for a diagnosis of probable DLB, one for possible DLB)
2-1 Fluctuating cognition with pronounced variations in attention and alertness
2-2 Recurrent visual hallucinations that are typically well formed and detailed
2-3 Spontaneous features of parkinsonism
3. Suggestive features (If one or more of these is present in the presence of one or more core features, a diagnosis of probable DLB can be made. In the absence of any core features, one or more suggestive features is sufficient for possible DLB. Probable DLB should
not be diagnosed on the basis of suggestive features alone.)
3-1 REM sleep behavior disorder
3-2 Severe neuroleptic sensitivity
3-3 Low dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET imaging

3. Primary progressive aphasia (PPA, Neurology 2011;76:1006)
1. Most prominent clinical feature is difficulty with language
2. These deficits are the principal cause of impaired daily living activities
3. Aphasia should be the most prominent deficit at symptom onset and for the initial phases of the disease
Key exclusion criteria 1) Cognitive dysfunction, systemic diseases or central nervous system other than CBS, PPA, and DLB (Schizophrenia, Bipolar disorder, Parkinson's disease, Vascular dementia, Huntington disease, brain tumor, Pick disease, Creutzfeldt-Jakob disease,Normal pressure hydrocephalus, Progressive supranuclear palsy,cerebral stroke, subdural hematoma, multiple sclerosis, epilepsy, HIV infection, neurosyphilis)
2. In the presence of any other physical illness such as Vitamine deficiency
3. In case physicians judge that the participants are mismatched.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumiko Motoi
Organization Juntendo University school of Medicine
Division name Department of Diagnosis, Prevention and Treatment of Dementia
Zip code
Address Bunkyo-ku Hongo 2-3-18 Regalo Ochanomizu II 602
TEL +81-3-5689-8556
Email motoi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Motoi
Organization Juntendo University school of Medicine
Division name Department of Diagnosis, Prevention and Treatment of Dementia
Zip code
Address Bunkyo-ku Hongo 2-3-18 Regalo Ochanomizu II 602
TEL +81-3-5689-8556
Homepage URL
Email motoi@juntendo.ac.jp

Sponsor
Institute Juntendo University school of Medicine
Department of Diagnosis, Prevention and Treatment of Dementia
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 28 Day
Last modified on
2016 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016388

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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