UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022860 |
|---|---|
| Receipt number | R000026341 |
| Scientific Title | Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2024/12/29 12:05:00 |
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Basic information
Public title
Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine
Acronym
Evaluation of cognitive, affective, olfactory function and sleep disturbance improvement in DLB patients treated with Galantamine
Scientific Title
Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine
Scientific Title:Acronym
Evaluation of cognitive, affective, olfactory function and sleep disturbance improvement in DLB patients treated with Galantamine
Region
| Japan |
Condition
Condition
DLB patients
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cogitive, affective, olfactory function, sleep disturbance improvement after treatment Galantamine in DLB patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of MMSE, HDS-R and FAB scores improvement after 1,3,6,9,12,15 months from dosage started
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We evaluate Galantamine in 8mg/day at first 4 weeks. After that, dosage increased 16mg/day.
Interventions/Control_2
Conrol patients
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DLB patients in our department who agreed to join our clinical trial
Key exclusion criteria
Patients treated with arrhythmia, epilepsy, bronchial asthma and severe obstructive uropathy. In addition, patients who occureed side effect of Galantamine during this clinical reseach
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Abe |
Organization
Okayama University
Division name
Neurology
Zip code
700-8558
Address
2-5-1, Shikatacho, Kita-ku, Okayama-shi, Okayama prefecture
TEL
086-235-7365
takemoto.demekin@gmail.com
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Takemoto |
Organization
Okayama Unversity
Division name
Neurology
Zip code
700-8558
Address
2-5-1, Shikatacho, Kita-ku, Okayama-shi, Okayama prefecture
TEL
086-235-7365
Homepage URL
takemoto.demekin@gmail.com
Sponsor or person
Institute
Department of Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Department of Neurology, Okayama University
Funding Source
Organization
Department of Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Neurology, Okayama University
Address
Department of Neurology, Okayama University
Tel
0862357365
demekin@cc.okayama-u.ac.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
岡山大学病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
https://okayama.bvits.com/esct/Apply/show.aspx?TYPE=6&ID=9587
Publication of results
Unpublished
Result
URL related to results and publications
https://okayama.bvits.com/esct/Apply/show.aspx?TYPE=6&ID=9587
Number of participants that the trial has enrolled
2
Results
Efficacy could not be assessed due to discontinuation cases only.
The study was terminated as the target number of patients could not be secured during the study period.
(2 cases conducted, 2 cases discontinued).
Results date posted
| 2024 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Outpatients of the Department of Neurology, Okayama University Hospital, who were diagnosed with DLB based on the revised International Workshop Diagnostic Criteria, and who agreed to participate in the study, were included in the study.
Participant flow
For the first case, the study was discontinued on 19 December 2017 due to the patient's request to go to a hospital closer to home for treatment than to a university hospital.
For the second case, the diagnosis changed to Alzheimer's disease instead of Lewy body dementia, so the name of the disease was changed on 23 January 2018, and the patient was removed from evaluation in the study and discontinued (2 cases performed, 2 discontinued).The study was terminated as no more patients were available for inclusion beyond these two cases and the target number of case-patients could not be secured during the study period.
Adverse events
There were none.
Outcome measures
Cognitive function score (MMSE HDS-R) before and after galantamine administration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026341
