UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014098 |
|---|---|
| Receipt number | R000016388 |
| Scientific Title | Clinical study for degenerative dementia |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2016/12/23 13:05:38 |
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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
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
motoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University school of Medicine
Department of Diagnosis, Prevention and Treatment of Dementia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016388
