UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Amyloid Imaging in Patients with Parkinson's disease
Title of the study (Brief title)	Evaluation of Amyloid Imaging in Parkinson's disease
Region	Japan

Condition
Condition	Parkinson disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to determine whether the amyloid burden, as indexed by 18F-florbetaben, identifies PD and whether amyloid burden affects cognitive decline and predicts clinical feature in subjects with PD.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Parkinson disease who have abnormal metabolism on positive amyloid PET (stage 2 preclinical AD) and those who have abnormal metabolism on an FDG-PET scan and normal amyloid PET (which may represent non-preclinical AD but suggest other neurological disease) will be monitored for a long term to assess changes in clinical features and cognitive function over time.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The study population consists of patients with PD, who are recruited in Keio Parkinson's Disease Database. All patients must be more than MMSE 26.
Key exclusion criteria	disaggrement
Target sample size	100

Research contact person
Name of lead principal investigator	Daisuke Ito
Organization	Keio University School of Medicine
Division name	Department of Neurology,
Address	35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL	03-5363-3788
Email	d-ito@jk9.so-net.ne.jp

Public contact
Name of contact person	Daisuke Ito
Organization	Keio University School of Medicine
Division name	Department of Neurology,
Address	35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL	03-5363-3788
Homepage URL
Email	d-ito@jk9.so-net.ne.jp

Sponsor
Institute	Department of Neurology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Piramal
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 06 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 06 Month 27 Day
Last follow-up date	2017 Year 05 Month 01 Day
Date of closure to data entry	2017 Year 05 Month 01 Day
Date trial data considered complete	2017 Year 05 Month 01 Day
Date analysis concluded	2017 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We report that PD without dementia shows an extremely low prevalence of beta Amyloid positivity compared to findings in cognitively normal elderly controls. Further longitudinal imaging studies and long-term follow-up of cognitive function are needed; however, our findings provide novel insights for a deeper understanding of beta Amyloid metabolism and deposition in PD.
Other related information	The subjects will undergo the following assessments: Amyloid PET (18F-florbetaben) Cognitive function tests (MMSE, CDR and MoCA-J) Assessments of symptoms and insight (UPDRS, NPI and GDS)

Management information
Registered date	2015 Year 06 Month 23 Day
Last modified on	2017 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020861