UMIN-CTR Clinical Trial

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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