UMIN-CTR Clinical Trial

Basic information
Public title	The effects of galantamine administration on brain network topology in patients with Alzheimer's disease (AD): A possible new biomarker for pharmacotherapy of AD
Acronym	The effects of galantamine administration on brain network topology in patients with Alzheimer's disease
Scientific Title	The effects of galantamine administration on brain network topology in patients with Alzheimer's disease (AD): A possible new biomarker for pharmacotherapy of AD
Scientific Title:Acronym	The effects of galantamine administration on brain network topology in patients with Alzheimer's disease
Region	Japan

Condition
Condition	mild to moderate Alzhiemer's disease
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to clarify whether ph-rsfcMRI could provide a possible biomarker for evaluation of galantamine treatment and prediction of response to pharmacological treatment in AD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Short-term effects of galantamine onto brain network topology, especially, difference in brain network states between galantamine administration and placebo administration.
Key secondary outcomes	For the participants who underwent 4W galantamine administration, we will evaluate long-term effects of galantamine as follows. 1.Differences in network topology parameters between galantamine responders (as defined in this protocol) and non-responders. Two types of comparisons will be made: (1) comparison of galantamine effects versus placebo effects before 4W galantamine administration and (2) effects of placebo administration before and after the 4W galantamine administration. 2.Correlation analysis between changes in network topology parameters and changes in ADAS-J cog scores and sub-scores before and after the 4W galantamine administration. 3.Correlation analysis between changes in network topology parameters and changes in CGI-I before and after the 4W galantamine administration.

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	galantamine 4 mg/day, 1 day or galantamine 4 mg/day, 4 week
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A diagnosis of probable AD according to criteria of the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDSADRDA) with Mini-Mental State Examination (MMSE) scores between 10 and 25.
Key exclusion criteria	1) Co-existing other neurodegenerative disease. 2) A history indicating excessive nicotine or alcohol intake (>0.5 packs of cigarettes, >4 glasses of an alcoholic substance a day), a severe allergy to pharmacological substances or their constitutive compounds, or the use of any experimental medication within 3months prior to the enrolment in the trial. 3) Patients with cardiovascular disease (e.g. myocardial infarction, valvulitis, or cardiomyopathy) or electrolyte imbalance (e.g. hypokalaemia). 4) Patients with severe liver dysfunction (Child-Pugh score of C) or severe renal dysfunction. 5) Exclusion criteria to MRI: presence of a pacemaker, metallic implants in high-risk areas (i.e. aneurysm clips) and a history of claustrophobia.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Hanakawa
Organization	Natinal Center of Neurology and Psychiatry
Division name	Integrative Brain Imaging Center
Zip code	187-8551
Address	4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL	042-346-2206
Email	hanakawa@ncnp.go.jp

Public contact
Name of contact person	1st name Mayumi Middle name Last name Inoue
Organization	Natinal Center of Neurology and Psychiatry
Division name	Integrative Brain Imaging Center
Zip code	187-8551
Address	-4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL	042-346-2206
Homepage URL
Email	mainoue@ncnp.go.jp

Sponsor
Institute	Natinal Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry Clinical Research Review Board
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel	042-341-2712-7828
Email	rinri-jimu@ncnp.go.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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 21 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	9
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	2015 Year 03 Month 31 Day
Date of IRB	2020 Year 02 Month 17 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 21 Day
Last modified on	2020 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021233