Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Rivastigmine (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Seoul National University Hospital
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.
Clinical Details
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)
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: the mean changes of Standardized Uptake Values (SUVmean) in PET imagingthe mean changes of serum BuChE activity between BuChE wild type and K-variant type
Secondary outcome: the mean changes of cortical thickness in brain MRIthe cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) the cognitive changes in Mini-Mental State Exam (MMSE) the daily function changes by Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI) the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) between BuChE wild type and K-variant type
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease (NINCD-ADRDA and MMSE between 10 ~26)
- Who didn't take Cholinesterase Inhibitor on liver within 3 months
Exclusion Criteria:
- diagnosed with diseases other than AD that affect brain atrophy according to Brain
MRI
- Diagnosed with diseases other than AD which affect cognitive functions (i. g.
Schizophrenia, Major Depression, Mental Retardation, encephalopathy, etc.)
- Didn't suspect of drug or alcohol addictions within last decade
- Unable to participate the study due to poor sight and hearing
- Who aren't suitable to participate according to the researchers' judgement
Locations and Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul 156-707, Korea, Republic of
Additional Information
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Starting date: February 2014
Last updated: May 12, 2015
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