UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018749 |
|---|---|
| Receipt number | R000021233 |
| 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 |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2020/08/24 12:45:48 |
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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
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
mainoue@ncnp.go.jp
Sponsor or person
Institute
Natinal Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021233
