UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Longitudinal study across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Title of the study (Brief title)	Longitudinal study across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to evaluate preclinical AD and MCI due to AD using PET amyloid imaging as a beta amyloid biomarker,and to clarify the progression of pre-symptomatic stage to AD dementia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)To investigate the deposits of beta-amyloid in brain cortex. 2)Degree of impairment of cognitive function correlate with beta-amyloid.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Three-dimensional Dynamic PET images of the brain will be acquired for 60min after intravenous administration of [11C-PIB](about 550 mBq ).
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	55 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1)The patients had underwent 11C-PIB PET in the past. 2)55years old-90years old,male and female. 3)Written informed consent was obtained from patient or his/her family.
Key exclusion criteria	1)The past and present history of alcoholism and epilepsy 2)The past and present history of psychiatric, disorders, cerebrovascular disease, degenerative disease of the brain and head injury. 3)Severe complication including malignancy, heart failure, hepatic dysfunction, renal dysfunction, endocrine disorders, etc 4)Patients treated with antidepressants, antipsychotics,and long-term sedative-hypnotics 5)The patients that investigators need to exclude.
Target sample size	160

Research contact person
Name of lead principal investigator	Shizuo Hatashita
Organization	Shonan-Atsugi hospital
Division name	Department of neurosurgery
Address	Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL	046-223-3636
Email	tiken2@shonan-atsugi.jp

Public contact
Name of contact person	Shizuo Hatashita
Organization	Shonan-Atsugi hospital
Division name	Department of neurosurgery
Address	Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL	046-297-7576
Homepage URL
Email	tiken2@shonan-atsugi.jp

Sponsor
Institute	Shonan-Atsugi hospital
Institute
Department

Funding Source
Organization	Department of neurosurgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 24 Day

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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 23 Day
Last modified on	2018 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016700