Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles
NCT ID: NCT02063269
Last Updated: 2015-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2014-02-28
2017-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Rivastigmine
Rivastigmine
Rivastigmine
9-18mg/rivastigmine for 52 weeks
Interventions
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Rivastigmine
9-18mg/rivastigmine for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Who didn't take Cholinesterase Inhibitor on liver within 3 months
Exclusion Criteria
* 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
55 Years
80 Years
ALL
No
Sponsors
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Novartis Korea Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Jun Young Lee
MD
Locations
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Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, , South Korea
Countries
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References
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Ames A 3rd. CNS energy metabolism as related to function. Brain Res Brain Res Rev. 2000 Nov;34(1-2):42-68. doi: 10.1016/s0165-0173(00)00038-2.
Blesa R, Bullock R, He Y, Bergman H, Gambina G, Meyer J, Rapatz G, Nagel J, Lane R. Effect of butyrylcholinesterase genotype on the response to rivastigmine or donepezil in younger patients with Alzheimer's disease. Pharmacogenet Genomics. 2006 Nov;16(11):771-4. doi: 10.1097/01.fpc.0000220573.05714.ac.
Davies P, Maloney AJ. Selective loss of central cholinergic neurons in Alzheimer's disease. Lancet. 1976 Dec 25;2(8000):1403. doi: 10.1016/s0140-6736(76)91936-x. No abstract available.
Fox MD, Raichle ME. Spontaneous fluctuations in brain activity observed with functional magnetic resonance imaging. Nat Rev Neurosci. 2007 Sep;8(9):700-11. doi: 10.1038/nrn2201.
Holmes C, Ballard C, Lehmann D, David Smith A, Beaumont H, Day IN, Nadeem Khan M, Lovestone S, McCulley M, Morris CM, Munoz DG, O'Brien K, Russ C, Del Ser T, Warden D. Rate of progression of cognitive decline in Alzheimer's disease: effect of butyrylcholinesterase K gene variation. J Neurol Neurosurg Psychiatry. 2005 May;76(5):640-3. doi: 10.1136/jnnp.2004.039321.
Kimura N, Kumamoto T, Masuda T, Hanaoka T, Okazaki T, Arakawa R. Evaluation of the regional cerebral blood flow changes during long-term donepezil therapy in patients with Alzheimer's disease using 3DSRT. J Neuroimaging. 2012 Jul;22(3):299-304. doi: 10.1111/j.1552-6569.2011.00612.x. Epub 2011 Jun 23.
Lane RM, Potkin SG, Enz A. Targeting acetylcholinesterase and butyrylcholinesterase in dementia. Int J Neuropsychopharmacol. 2006 Feb;9(1):101-24. doi: 10.1017/S1461145705005833. Epub 2005 Aug 5.
Levy JA, Parasuraman R, Greenwood PM, Dukoff R, Sunderland T. Acetylcholine affects the spatial scale of attention: evidence from Alzheimer's disease. Neuropsychology. 2000 Apr;14(2):288-98. doi: 10.1037//0894-4105.14.2.288.
Nobili F, Koulibaly M, Vitali P, Migneco O, Mariani G, Ebmeier K, Pupi A, Robert PH, Rodriguez G, Darcourt J. Brain perfusion follow-up in Alzheimer's patients during treatment with acetylcholinesterase inhibitors. J Nucl Med. 2002 Aug;43(8):983-90.
O'Brien KK, Saxby BK, Ballard CG, Grace J, Harrington F, Ford GA, O'Brien JT, Swan AG, Fairbairn AF, Wesnes K, del Ser T, Edwardson JA, Morris CM, McKeith IG. Regulation of attention and response to therapy in dementia by butyrylcholinesterase. Pharmacogenetics. 2003 Apr;13(4):231-9. doi: 10.1097/00008571-200304000-00008.
Poirier J. Evidence that the clinical effects of cholinesterase inhibitors are related to potency and targeting of action. Int J Clin Pract Suppl. 2002 Jun;(127):6-19.
Silverman JM, Ciresi G, Smith CJ, Marin DB, Schnaider-Beeri M. Variability of familial risk of Alzheimer disease across the late life span. Arch Gen Psychiatry. 2005 May;62(5):565-73. doi: 10.1001/archpsyc.62.5.565.
Ki CS, Na DL, Kim JW, Kim HJ, Kim DK, Yoon BK. No association between the genes for butyrylcholinesterase K variant and apolipoprotein E4 in late-onset Alzheimer's disease. Am J Med Genet. 1999 Apr 16;88(2):113-5. doi: 10.1002/(sici)1096-8628(19990416)88:23.0.co;2-3.
Kim KW, Jhoo JH, Lee JH, Lee KU, Lee DY, Youn JC, Youn JY, Woo JI. Neither the butyrylcholinesterase K variant nor transferrin C2 variant confers a risk for Alzheimer's disease in Koreans. J Neural Transm (Vienna). 2001;108(10):1159-66. doi: 10.1007/s007020170005.
Jagust WJ, Bandy D, Chen K, Foster NL, Landau SM, Mathis CA, Price JC, Reiman EM, Skovronsky D, Koeppe RA; Alzheimer's Disease Neuroimaging Initiative. The Alzheimer's Disease Neuroimaging Initiative positron emission tomography core. Alzheimers Dement. 2010 May;6(3):221-9. doi: 10.1016/j.jalz.2010.03.003.
Other Identifiers
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CENA713DKR15T
Identifier Type: -
Identifier Source: org_study_id
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