Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Drug: Rivastigmine

• Registration Number: NCT02063269
• Lead Sponsor: Seoul National University Hospital

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 butyrylc...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-14
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rivastigmine	Rivastigmine	Rivastigmine

Primary Outcome Measures

Name	Time	Method
the mean changes of Standardized Uptake Values (SUVmean) in PET imaging	screening and 52weeks (2 times)	Unit: mg/100g/min
the mean changes of serum BuChE activity between BuChE wild type and K-variant type	screening and 52weeks (2 times)	unit of umil ACSCh/h/mg

Secondary Outcome Measures

Name	Time	Method
the mean changes of cortical thickness in brain MRI	screening and 52weeks (2 times)	unit of mm
the cognitive changes in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)	screening, 26, and 52 weeks (3 times)	unit in points
the cognitive changes in Mini-Mental State Exam (MMSE)	screening, 26, and 52 weeks (3 times)	unit in points
the daily function changes by Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)	screening, 26, and 52 weeks (3 times)	unit in points
the behavioural changes by Caregiver-Administered Neuropsychiatric Inventory (NPI)	screening, 26, and 52 weeks (3 times)	unit in points
the disease severity changes by Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) between BuChE wild type and K-variant type	screening, 26, and 52 weeks (3 times)	unit in points

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of