Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 2:05 PM
Study NCT ID:
NCT02063269
Status:
UNKNOWN
Last Update Posted:
2015-05-14
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Differences of Functional Changes in Brain by Rivastigmine According to Butyrylcholinesterase Alleles in Alzheimer's Disease Patients(Rivastigmine, Imaging, and BuChE in AD: RIBA)
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Butyrylcholinesterase (BuChE) activity is increasing in Alzheimer Disease (AD) process (Lane et al., 2006). BuChE wild type has stronger butyrylcholine esterase activity than BuChE K variant allele and this strong activity can affect AD brain negatively by choline depletion. Rivastigmine has unique dual action - acetylcholine esterase inhibition and butyrylcholine esterase inhibition. Therefore, rivastigmine can lower serum butyrylcholine esterase activity and delay functional decrease of Fluorodeoxyglucose positron emission tomography (FDG PET) images in AD patients with BuChE wild type allele by strong BuChE inhibition.
It suggests that rivastigmine can affect brain function differently by BuChE genotype in AD. Therefore, we will try to find the different changes of serum butyrylcholine esterase activity by ELISA and functional and structural changes of brain between BuChE wild type and K-variant type by FDG PET and MRI pre and post images after 12 month use of rivastigmine.
1. Primary objective:
1. the mean changes of Standardized Uptake Values (SUVmean) in PET imaging
2. the mean changes of serum BuChE activity between BuChE wild type and K-variant type.
2. Secondary objectives:
1. the mean changes of cortical thickness in brain MRI
2. the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
3. the cognitive changes in Mini-Mental State Exam (MMSE)
4. the daily function changes by Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
5. the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)
6. the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) between BuChE wild type and K-variant type.
It suggests that rivastigmine can affect brain function differently by BuChE genotype in AD. Therefore, we will try to find the different changes of serum butyrylcholine esterase activity by ELISA and functional and structural changes of brain between BuChE wild type and K-variant type by FDG PET and MRI pre and post images after 12 month use of rivastigmine.
1. Primary objective:
1. the mean changes of Standardized Uptake Values (SUVmean) in PET imaging
2. the mean changes of serum BuChE activity between BuChE wild type and K-variant type.
2. Secondary objectives:
1. the mean changes of cortical thickness in brain MRI
2. the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
3. the cognitive changes in Mini-Mental State Exam (MMSE)
4. the daily function changes by Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
5. the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)
6. the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) between BuChE wild type and K-variant type.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: