UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037320 |
|---|---|
| Receipt number | R000042358 |
| Scientific Title | Amyloid imaging study for alcohol use disorder: Observational study using PET |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2024/07/28 08:17:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Amyloid imaging study for alcohol use disorder: Observational study using PET
Acronym
Amyloid PET study for alcohol use disorder
Scientific Title
Amyloid imaging study for alcohol use disorder: Observational study using PET
Scientific Title:Acronym
Amyloid PET study for alcohol use disorder
Region
| Japan |
Condition
Condition
Alcohol use disorder
Alcohol related dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate amyloid accumulation in brain of subjects with alcohol use disorder and alcohol related dementia.
Basic objectives2
Others
Basic objectives -Others
To compare amyloid accumulation between alcohol use disorder to alcohol related dementia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standardized uptake value ratio versus cerebellum in cortex and hippocampus
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Alcohol dependent group
1) Men and women aged between 30 to 75 who meet a criteria of alcohol dependence in DSM-IV (or have met the criteria) and receive treatment for alcohol dependence
2) Those who have not drink alcohol for more than 30 days at the screening point
Healthy control group
1) Physically healthy men and women who have never met any DSM-IV criterion except nicotine dependence
Key exclusion criteria
Alcohol dependent group
1) Meet a criteria of dependence of other psychotropic substance
2) Those who likely to had met any DSM-IV criterion other than alcohol dependence before develop alcohol dependence
Healthy control group
1) Those who have met any DSM-IV criterion except nicotine dependence
2) Those who have cognitive impairment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kyoji |
| Middle name | |
| Last name | Okita |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
187-8551
Address
4-1-1 Ogawa-higashi, Kordaira, Tokyo
TEL
042-341-2711
KOkita@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kyoji |
| Middle name | |
| Last name | Okita |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
187-8551
Address
4-1-1 Ogawa-higashi, Kordaira, Tokyo
TEL
042-341-2711
Homepage URL
KOkita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
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
Institutional Review Board at National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-higashi, Kordaira, Tokyo
Tel
042-341-2711
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
| 2019 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.osake-kagaku.or.jp/grant/pdf/report_2021_okita.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.osake-kagaku.or.jp/grant/pdf/report_2021_okita.pdf
Number of participants that the trial has enrolled
50
Results
Twenty four individuals with alcohol use disorder (AUD) and 26 healthy controls participated in the study. AUD group showed lower cognitive performance. MRI scan revealed lower mean kurtosis value in the brain including gray matter- and white matter- area in AUD group. Besides, PET scan with 11C-PiB has shown lower SUV in AUD group. Those results suggests integrity of white matter in AUD is impaired.
Results date posted
| 2024 | Year | 07 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Individuals with alcohol use disorder and healthy controls
Participant flow
We recruited the participants in the self help group and public community centers using flyers.
Adverse events
None
Outcome measures
11C -PiB PET scan and DKI MRI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Observation study utilizing PET
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042358
