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Recruitment status Completed
Unique ID issued by UMIN UMIN000011135
Receipt No. R000012883
Scientific Title Prediction of symptomatic response to galantamine treatment by regional cerebral blood flow measurement in Alzheimer's disease patients.
Date of disclosure of the study information 2013/07/08
Last modified on 2015/06/17

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Basic information
Public title Prediction of symptomatic response to galantamine treatment by regional cerebral blood flow measurement in Alzheimer's disease patients.
Acronym The response to galantamine in Alzheimer's disease patients.
Scientific Title Prediction of symptomatic response to galantamine treatment by regional cerebral blood flow measurement in Alzheimer's disease patients.
Scientific Title:Acronym The response to galantamine in Alzheimer's disease patients.
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether the change in rCBF at initial treatment period can be a good predictor to assess long term outcomes of galantine treatment in AD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neurological test: ADAS-J Cog, MMSE
rCBF measurement using SPECT
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

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 Object:Patients with mild to moderate Alzheimer's disease.
Duration:1 year
Drug:galantamine
Evaluation:Cerebral blood flow with ECD-SPECT, ADAS-J cog, MMSE at each time point.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria Age older than 65 years old.
Diagnosed as mild to moderate Alzheimer's disease.
Non medicated.
Key exclusion criteria Severe Alzheimer's disease
Dementia with Lewy body
Frontal-temporal type dementia
Vascular dementia
Sixty-five years old and younger
With a history of medication with anti-dementia drug
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Hirata
Organization Toho University, Ohashi Medical Center
Division name Department of Neurosurgery
Zip code
Address Toho university medical center, Ohashi hospital
TEL 03-3481-7319
Email yokochan3@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Hirata
Organization Toho university medical center, Ohashi hospital
Division name Department of Neurosurgery
Zip code
Address 2-17-6, Ohashi, Meguro-ku, Tokyo
TEL 03-3481-7319
Homepage URL
Email yokochan3@gmail.com

Sponsor
Institute Toho University, Ohashi Medical Center, Department of Neurosurgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Janssen Pharmaceutical K.K.
Scientific Affairs Division
CNS Science Dept.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東邦大学医療センター大橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 08 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
Results
Ten patients (10/28) responded to the treatment. No difference was observed in the MMSE score at the baseline, however ADAS J-cog score in responders (responders 16.1+/- 6.4; nonresponders 10.1+/-3.1). The SPECT analysis demonstrated that rCBF in the posterior cingulate gyrus of responders were preserved.
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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 06 Day
Last modified on
2015 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012883


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