UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of prospective memory process with the Cambridge Prospective Memory Test (CAMPROMPT)-Japanese
Title of the study (Brief title)	The investigation of prospective memory process with CAMPROMPT-Japanese
Region	Japan

Condition
Condition	Cerebrovascular disease Traumatic brain injury Mild cognitive impairment Alzheimer's disease Frontotemporal dementia Dementia with Lewy bodies
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate prospective memory impairment with the Cambridge Prospective Memory Test (CAMPROMPT)-Japanese
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Cambridge Prospective Memory Test (CAMPROMPT)-Japanese
Key secondary outcomes	Wechsler Adult Intelligence Scale 3/Revised Mini-Mental State Examination Kana-hiroi test Supplementary Tests for Standard Language Test of Aphasia,"Explanation of Katoons" The Rivermead Behavioural Memory Test-Japanese with check lists Behavioural Assessment of the Dysexecutive Syndrome-Japanese with DEX questionaires

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with memory impairment or/and frontal function impairment after acquired cerebral damage
Key exclusion criteria	1.Patients with aphasia 2.Patients with depression or some psychiatric disease 3. Patients with congenital mental retardation 4. Patients with severe dementia
Target sample size	100

Research contact person
Name of lead principal investigator	Jun Tanemura
Organization	Kawasaki University of Medical Welfare
Division name	Faculty of Health Science and Technology, Department of Sensory Science
Address	288 Matushima Kurashiki-city Okayama-prefecture
TEL	086-427-1111(54631)
Email

Public contact
Name of contact person	Jun Tanemura
Organization	Kawasaki University of Medical Welfare
Division name	Faculty of Health Science and Technology, Department of Sensory Science
Address	288 Matushima Kurashiki-city Okayama-prefecture
TEL	086-427-1111(54631)
Homepage URL
Email	tanemura@mw.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki University of Medical Welfare
Institute
Department

Funding Source
Organization	Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kawasaki Medical School Hospital Kawasaki Hpopital, Kawasaki Medical School
Name of secondary funｄer(s)	None

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	2009 Year 06 Month 10 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2009 Year 03 Month 01 Day
Anticipated trial start date	2009 Year 03 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
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	To investigate prospective memory impaiment with CAMPROMPT.

Management information
Registered date	2009 Year 05 Month 14 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002396