Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe

There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD. This was an international, multicenter, double-...

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Vydané v:	Neurology Ročník 74; číslo 12; s. 956
Hlavní autori:	Feldman, H H, Doody, R S, Kivipelto, M, Sparks, D L, Waters, D D, Jones, R W, Schwam, E, Schindler, R, Hey-Hadavi, J, DeMicco, D A, Breazna, A
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 23.03.2010
Predmet:	Aged Aged, 80 and over Alzheimer Disease - drug therapy Alzheimer Disease - metabolism Atorvastatin Calcium Cholesterol, LDL - metabolism Cholinergic Antagonists - therapeutic use Double-Blind Method Female Heptanoic Acids - therapeutic use Hippocampus - pathology Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Magnetic Resonance Imaging Male Middle Aged Organ Size - drug effects Pyrroles - therapeutic use
ISSN:	1526-632X, 1526-632X
On-line prístup:	Zistit podrobnosti o prístupe
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Abstract	There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD. This was an international, multicenter, double-blind, randomized, parallel-group study. Subjects had mild to moderate probable AD (Mini-Mental State Examination score 13-25), were aged 50-90 years, and were taking donepezil 10 mg daily for > or 3 months prior to screening. Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and < 195 mg/dL. Patients were randomized to atorvastatin 80 mg/day or placebo for 72 weeks followed by a double-blind, 8-week atorvastatin withdrawal phase. Coprimary endpoints were changes in cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and global function (Alzheimer's Disease Cooperative Study Clinical Global Impression of Change [ADCS-CGIC]) at 72 weeks. A total of 640 patients were randomized in the study. There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints. Atorvastatin was generally well-tolerated. In this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks. This treatment was generally well-tolerated without unexpected adverse events. This study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo.
AbstractList	There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD. This was an international, multicenter, double-blind, randomized, parallel-group study. Subjects had mild to moderate probable AD (Mini-Mental State Examination score 13-25), were aged 50-90 years, and were taking donepezil 10 mg daily for > or 3 months prior to screening. Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and < 195 mg/dL. Patients were randomized to atorvastatin 80 mg/day or placebo for 72 weeks followed by a double-blind, 8-week atorvastatin withdrawal phase. Coprimary endpoints were changes in cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and global function (Alzheimer's Disease Cooperative Study Clinical Global Impression of Change [ADCS-CGIC]) at 72 weeks. A total of 640 patients were randomized in the study. There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints. Atorvastatin was generally well-tolerated. In this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks. This treatment was generally well-tolerated without unexpected adverse events. This study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo. There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD.BACKGROUNDThere is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial (RCT) evaluating the efficacy and safety of atorvastatin in patients with mild to moderate AD.This was an international, multicenter, double-blind, randomized, parallel-group study. Subjects had mild to moderate probable AD (Mini-Mental State Examination score 13-25), were aged 50-90 years, and were taking donepezil 10 mg daily for > or 3 months prior to screening. Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and < 195 mg/dL. Patients were randomized to atorvastatin 80 mg/day or placebo for 72 weeks followed by a double-blind, 8-week atorvastatin withdrawal phase. Coprimary endpoints were changes in cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and global function (Alzheimer's Disease Cooperative Study Clinical Global Impression of Change [ADCS-CGIC]) at 72 weeks.METHODSThis was an international, multicenter, double-blind, randomized, parallel-group study. Subjects had mild to moderate probable AD (Mini-Mental State Examination score 13-25), were aged 50-90 years, and were taking donepezil 10 mg daily for > or 3 months prior to screening. Entry low-density lipoprotein cholesterol levels (LDL-C) were > 95 and < 195 mg/dL. Patients were randomized to atorvastatin 80 mg/day or placebo for 72 weeks followed by a double-blind, 8-week atorvastatin withdrawal phase. Coprimary endpoints were changes in cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog]) and global function (Alzheimer's Disease Cooperative Study Clinical Global Impression of Change [ADCS-CGIC]) at 72 weeks.A total of 640 patients were randomized in the study. There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints. Atorvastatin was generally well-tolerated.RESULTSA total of 640 patients were randomized in the study. There were no significant differences in the coprimary endpoints of ADAS-cog or ADCS-CGIC or the secondary endpoints. Atorvastatin was generally well-tolerated.In this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks. This treatment was generally well-tolerated without unexpected adverse events.CONCLUSIONSIn this large-scale randomized controlled trial evaluating statin therapy as a treatment for mild to moderate Alzheimer disease, atorvastatin was not associated with significant clinical benefit over 72 weeks. This treatment was generally well-tolerated without unexpected adverse events.This study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo.CLASSIFICATION OF EVIDENCEThis study provides Class II evidence that intensive lipid lowering with atorvastatin 80 mg/day in patients with mild to moderate probable Alzheimer disease (aged 50-90), taking donepezil, with low-density lipoprotein cholesterol levels between 95 and 195 mg/dL over 72 weeks does not benefit cognition (as measured by Alzheimer's Disease Assessment Scale-Cognitive Subscale) (p = 0.26) or global function (as measured by Alzheimer's Disease Cooperative Study Clinical Global Impression of Change) (p = 0.73) compared with placebo.
Author	Schwam, E Kivipelto, M Jones, R W Sparks, D L Breazna, A DeMicco, D A Feldman, H H Hey-Hadavi, J Waters, D D Schindler, R Doody, R S
Author_xml	– sequence: 1 givenname: H H surname: Feldman fullname: Feldman, H H email: hfeldman@interchange.ubc.ca organization: Division of Neurology, University of British Columbia, UBCH Clinic for Alzheimer's Disease and Related Disorders, Vancouver, Canada. hfeldman@interchange.ubc.ca – sequence: 2 givenname: R S surname: Doody fullname: Doody, R S – sequence: 3 givenname: M surname: Kivipelto fullname: Kivipelto, M – sequence: 4 givenname: D L surname: Sparks fullname: Sparks, D L – sequence: 5 givenname: D D surname: Waters fullname: Waters, D D – sequence: 6 givenname: R W surname: Jones fullname: Jones, R W – sequence: 7 givenname: E surname: Schwam fullname: Schwam, E – sequence: 8 givenname: R surname: Schindler fullname: Schindler, R – sequence: 9 givenname: J surname: Hey-Hadavi fullname: Hey-Hadavi, J – sequence: 10 givenname: D A surname: DeMicco fullname: DeMicco, D A – sequence: 11 givenname: A surname: Breazna fullname: Breazna, A
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/20200346$$D View this record in MEDLINE/PubMed
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ContentType	Journal Article
Contributor	Schulz, J B Macina, L O Bernick, C B Kivipelto, Miia Inglis, F Rovira, M B Fink, M Maud, C M Poewe, D McCarthy, J A Hecker, J Baldwin, A Hogan, D B Levin, K A Kurz, A Jones, Roy Dal-Bianco, P Haushofer, M Laban, P R Clarnette, R De la Gandara, J E Andreasen, N Garcia, A F Dempsey, G M Kaye, J A Green, P M Raskind, M A Ismail, M S Dekosky, S T Steinhagen-Thiessen, E Ayuso, J L D Woodward, M C Coles, R Wilkinson, D Sparks, David Lawrence Margolin, D I Olofsson, H Borrie, M J Hasselbalch, S G Doody, R S Krishnasastry, C S Bayer, A Smuts, A Jakobsen, S A McKenney, J M Richter, R W Molinuevo, J L Chang, F F Doody, Rachelle Mattes, J A Maier, W Jones, R W Brodaty, H Kalafer, M Boundy, K Horn, R Pittard, J M Rainer, M Drachman, D A Black, S E Londborg, P D Dengiz, A N Potocnik, F C Feldman, Howard Nunez, M C Barbera, M A Holub, R F Bullock, R A Asthana, S M Lipschitz, S Yates, M W Feldman, H Duboff, E A Cooper, G E Marcusson, J Lauritzen, L F Mattern, W Macknight, C Holland, P J Garcia, C F Waters, David Crimmins, D S Karnath, H-O Preston, W G Folks, D G Antuono, P G Moeller,
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References	21036979 - Evid Based Ment Health. 2010 Nov;13(4):117 20200345 - Neurology. 2010 Mar 23;74(12):945-6
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Snippet	There is some evidence that statins may have a protective and symptomatic benefit in Alzheimer disease (AD). The LEADe study is a randomized controlled trial...
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SubjectTerms	Aged Aged, 80 and over Alzheimer Disease - drug therapy Alzheimer Disease - metabolism Atorvastatin Calcium Cholesterol, LDL - metabolism Cholinergic Antagonists - therapeutic use Double-Blind Method Female Heptanoic Acids - therapeutic use Hippocampus - pathology Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Magnetic Resonance Imaging Male Middle Aged Organ Size - drug effects Pyrroles - therapeutic use
Title	Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe
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