Ignite Creation Date:
2024-05-06 @ 2:33 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02063269
Status:
UNKNOWN
Last Update Posted:
2015-05-14
First Post:
2014-02-12
Brief Title:
Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Differences of Functional Changes in Brain by Rivastigmine According to Butyrylcholinesterase Alleles in Alzheimers Disease PatientsRivastigmine 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 Alzheimers Disease Assessment Scale-cognitive subscale ADAS-cog
3 the cognitive changes in Mini-Mental State Exam MMSE
4 the daily function changes by Alzheimers 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 Alzheimers Disease Assessment Scale-cognitive subscale ADAS-cog
3 the cognitive changes in Mini-Mental State Exam MMSE
4 the daily function changes by Alzheimers 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:
None
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?:
None