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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019926
Receipt No. R000022596
Scientific Title Clinical and neuroimaging study on preclinical Alzheimer's disease.
Date of disclosure of the study information 2015/12/01
Last modified on 2021/04/02

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Basic information
Public title Clinical and neuroimaging study on preclinical Alzheimer's disease.
Acronym AMED-Preclinical
Scientific Title Clinical and neuroimaging study on preclinical Alzheimer's disease.
Scientific Title:Acronym AMED-Preclinical
Region
Japan

Condition
Condition mild cognitive impairment, preclinical Alzheimer disease
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This clinical study aims to discriminate MCI individuals at risk for development of Alzheimer dementia, as well as preclinical AD without clinical manifestations.
Basic objectives2 Others
Basic objectives -Others It is necessary to start treatment at the earliest stage of Alzheimer disease to successfully develop drugs (disease-modifying therapies: DMTs). This study aims to establish the criteria for evaluation of the earliest stage of Alzheimer disease and to analyze the genes that related Alzheimer disease.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive assessments, brain imaging, and biomarkers in cerebrospinal fluid, and estimation of conversion rate from asymptomatic preclinical AD to MCI and further to AD dementia.
Key secondary outcomes The evaluation of correlation among indexes such as amyloid-PET, neuropsychometry, brain imaging, and biomarkers in cerebrospinal fluid. Genetic analysis of APP, presenilin (PSEN 1,PSEN 2) and related genes (MAPT,PGRNetc.), and comparison between the phenotype (symptoms) and the genotype of whole genome.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Neuroimaging study using PET diagnostics not yet approved for diagnostic indications (brain PET scan using 11C-PiB, florbetapir or flutemetamol at 0 and 36 months)
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
60 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Preclinical AD study: 150 amyloid PET-positive and 150 amyloid PET-negative cognitively normal individuals, whose language is Japanese.
2. MCI study: 100 late MCI and 100 early MCI individuals who meet with the criteria of each type of MCI (below).
3. Living at home, accompanied by a study partner who has a direct contact with the participant >10 hr per week. The participant should be accompanied by the study partner at every visit throughout the study.
4.The participants and study partners should sign agreement forms.
5. Age: 65-85 years (preclinical AD study) and 60-85 years (MCI study) upon enrollment. Individuals of both sexes will be enrolled.
6a. Criteria for participants in preclinical AD study
MMSE: 24-30
Scores of Wechsler memory Scale-R logical memory II (corrected for education), above the cut-off levels.
education 0-7 years: 3 or above
8-15 years: 5 or above
>16 years 9 or above
CDR 0, not depressed
Individuals who are amyloid PET-positive upon screen scan are categorized as "preclinical AD" and amyloid PET-negative as "normal aged".
6b. Criteria for amnestic MCI
Memory disturbance approved by the participant or study partner or clinician.
MMSE: 24-30
Scores of Wechsler memory Scale-R logical memory II (corrected for education), below the cut-off levels.
education 0-7 years: 2 or lower (late MCI); 3-6 (early MCI)
10-15 years: 4 or lower (late MCI); 5-9 (early MCI)
>16 years 8 or lower (late MCI); 9-11 (early MCI)
CDR 0.5 not depressed
Key exclusion criteria 1. Parkinson' disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy or other neurodegenerative diseases other than AD. Multiple cerebral infarction, normal pressure hydrocephalus, brain tumor, epilepsy, subdural hematoma, multiple sclerosis, head trauma with sequelae will also be excluded.
2. Signs of brain infection, focal brain lesions (eg infarction) that may affect cognitive function. Individuals with subcortical small infarction or diffuse white matter lesions can be included except for those in specific lesions affecting cognition. Cortical infarcts are normally excluded.
3. Presence of pacemaker, arterial clip, artificial valves, artificial cochlea, and other magnetic/electroconductive metals in the body that may affect MRI scan.
4. Major depression or bipolar disorder within past 1 year, past history of schizophrenia, defined by DSM-IV.
5. Addiction to alcohol or other drugs within past 2 years.
6. Past history of psychiatric symptoms, agitation or abnormal behaviors that affect protocol adherence within past 3 months.
7. Presence of fatal or unstable diseases.
8. Vitamin B12 or folate deficiency, syphilis, thyroid function abnormality.
9. Admission to care home or hospitals.
10. Administration of specific drugs (defined in the procedure manual) including psychoactive drugs and warfarin.
11. Administration of any drugs in clinical trial within 1 month prior to screening.
12. Participation in clinical studies or clinical trials other than AMED preclinical.
13. Probable participation in clinical trials for Alzheimer's disease drugs during the study duration of 3 years.
14. Decision of exclusion otherwise judged by site study physician or clinical core.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Shimada
Organization Graduate School of medicine, Osaka City University
Division name Department of Diagnostic and Interventional Radiology
Zip code 545-8585
Address 1-4-3 Asahimachi, Abenoku, Osaka
TEL 06-6646-6185
Email h.shimada@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Shimada
Organization Graduate School of medicine, Osaka City Nuversity
Division name Center for Clinical study on dementia
Zip code 545-8585
Address 1-4-3 Asahimachi, Abenoku, Osaka
TEL 06-6646-6185
Homepage URL
Email h.shimada@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka city university hospital and 35 hospitals in Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka City University Hospital Certified Review Board
Address AbenoMedix 6F, 1-2-7, Asahi-machi Abeno-ku, Osaka, 545 -8585, Japan Osaka
Tel 06-6645-3456
Email irb@med.osaka-cu.ac.jp

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 大阪市立大学医学部附属病院と全国35医療研究機関
Osaka city university hospital and other 35 hospitals in Japan

Other administrative information
Date of disclosure of the study information
2015 Year 12 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 40
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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
2015 Year 09 Month 01 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information AMED Preclinical AD study Manuscript Citations (Sep 2020)

By-line:

Include the phrase "AMED Preclinical AD study *" with the asterisk referring to the following statement and list of names:

*Data used in preparation of this article were obtained from the AMED Preclinical AD study database deposited in the National Bioscience Database Center Human Database, Japan (Research ID: hum0235.v1, 2020). As such, the investigators within AMED Preclinical AD study contributed to the design and implementation of AMED Preclinical AD study and/or provided data but did not participate in analysis or writing of this report.

A complete listing of AMED Preclinical AD study investigators can be found at:
https:// humandbs.biosciencedbc.jp/en/hum0235-amed-pre-authors .

Methods Section:

Data used in preparation of this article were obtained from the AMED Preclinical AD study database deposited in the National Bioscience Database Center Human Database, Japan (Research ID: hum0235.v1, 2020). The AMED Preclinical AD study was launched in 2015 led by Principal Investigator Hiroshi Mori, PhD. The primary goal of AMED Preclinical AD study has been to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to measure the progression of early and late mild cognitive impairment (MCI) and Preclinical Alzheimer's disease (AD) in the Japanese population.

Acknowledgements Section:

AMED Preclinical AD study was supported by the grant of the Japan Agency for Medical Research and Developmential.

Management information
Registered date
2015 Year 11 Month 25 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022596

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2021/03/24 AMED Pre AD-Citations.pdf

Research case data
Registered date File name


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