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 |
Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine
Evaluation of cognitive, affective, olfactory function and sleep disturbance improvement in DLB patients treated with Galantamine
Evaluation of cognitive, affective, olfactory functions and sleep disturbance improvement in Dementia with Lewy Bodies patients treated with Galantamine
Evaluation of cognitive, affective, olfactory function and sleep disturbance improvement in DLB patients treated with Galantamine
Japan |
DLB patients
Neurology |
Others
NO
To evaluate cogitive, affective, olfactory function, sleep disturbance improvement after treatment Galantamine in DLB patients
Efficacy
Evaluation of MMSE, HDS-R and FAB scores improvement after 1,3,6,9,12,15 months from dosage started
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
2
Treatment
Medicine |
We evaluate Galantamine in 8mg/day at first 4 weeks. After that, dosage increased 16mg/day.
Conrol patients
20 | years-old | < |
90 | years-old | >= |
Male and Female
DLB patients in our department who agreed to join our clinical trial
Patients treated with arrhythmia, epilepsy, bronchial asthma and severe obstructive uropathy. In addition, patients who occureed side effect of Galantamine during this clinical reseach
50
1st name | Koji |
Middle name | |
Last name | Abe |
Okayama University
Neurology
700-8558
2-5-1, Shikatacho, Kita-ku, Okayama-shi, Okayama prefecture
086-235-7365
takemoto.demekin@gmail.com
1st name | Mami |
Middle name | |
Last name | Takemoto |
Okayama Unversity
Neurology
700-8558
2-5-1, Shikatacho, Kita-ku, Okayama-shi, Okayama prefecture
086-235-7365
takemoto.demekin@gmail.com
Department of Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Neurology, Okayama University
Department of Neurology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Self funding
Department of Neurology, Okayama University
Department of Neurology, Okayama University
0862357365
demekin@cc.okayama-u.ac.jp
NO
岡山大学病院(岡山県)
2016 | Year | 06 | Month | 23 | Day |
https://okayama.bvits.com/esct/Apply/show.aspx?TYPE=6&ID=9587
Unpublished
https://okayama.bvits.com/esct/Apply/show.aspx?TYPE=6&ID=9587
2
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).
2024 | Year | 12 | Month | 29 | Day |
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.
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.
There were none.
Cognitive function score (MMSE HDS-R) before and after galantamine administration
Preinitiation
2016 | Year | 08 | Month | 18 | Day |
2016 | Year | 09 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2016 | Year | 06 | Month | 23 | Day |
2024 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026341