PMID- 31417957
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 2352-8737 (Electronic)
IS  - 2352-8737 (Linking)
VI  - 5
DP  - 2019
TI  - Disease severity and minimal clinically important differences in clinical outcome 
      assessments for Alzheimer's disease clinical trials.
PG  - 354-363
LID - 10.1016/j.trci.2019.06.005 [doi]
AB  - INTRODUCTION: This study estimated the minimal clinically important difference 
      (MCID) for Mini Mental State Examination, Clinical Dementia Rating Scale sum of 
      boxes, and Functional Activities Questionnaire across the Alzheimer's disease 
      (AD) spectrum. METHODS: Retrospective analysis of the National Alzheimer's 
      Coordinating Center Uniform Data Set (9/2005-9/2016) and MCID for clinical 
      outcomes were estimated using anchor-based (clinician's assessment of meaningful 
      decline) and distribution-based (1/2 baseline standard deviation) approaches, 
      stratified by severity of cognitive impairment. RESULTS: On average, a 1-3 point 
      decrease in Mini Mental State Examination, 1-2 point increase in Clinical 
      Dementia Scale sum of boxes, and 3-5 point increase in Functional Activities 
      Questionnaire were indicative of a meaningful decline. The MCID values generally 
      increased by disease severity; the effect size and standardized response mean for 
      those with meaningful decline were consistently in the acceptable ranges for 
      MCID. DISCUSSION: These findings can inform design and interpretation of future 
      clinical trials.
FAU - Andrews, J Scott
AU  - Andrews JS
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
FAU - Desai, Urvi
AU  - Desai U
AD  - Analysis Group, Inc., Boston, MA, USA.
FAU - Kirson, Noam Y
AU  - Kirson NY
AD  - Analysis Group, Inc., Boston, MA, USA.
FAU - Zichlin, Miriam L
AU  - Zichlin ML
AD  - Analysis Group, Inc., Boston, MA, USA.
FAU - Ball, Daniel E
AU  - Ball DE
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
FAU - Matthews, Brandy R
AU  - Matthews BR
AD  - Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
LA  - eng
GR  - P50 AG005142/AG/NIA NIH HHS/United States
GR  - P50 AG016573/AG/NIA NIH HHS/United States
GR  - P50 AG047266/AG/NIA NIH HHS/United States
GR  - P30 AG010161/AG/NIA NIH HHS/United States
GR  - P50 AG025688/AG/NIA NIH HHS/United States
GR  - P50 AG005133/AG/NIA NIH HHS/United States
GR  - P50 AG005138/AG/NIA NIH HHS/United States
GR  - P50 AG047366/AG/NIA NIH HHS/United States
GR  - P30 AG019610/AG/NIA NIH HHS/United States
GR  - P30 AG028383/AG/NIA NIH HHS/United States
GR  - P50 AG033514/AG/NIA NIH HHS/United States
GR  - P30 AG013854/AG/NIA NIH HHS/United States
GR  - P30 AG053760/AG/NIA NIH HHS/United States
GR  - P30 AG010124/AG/NIA NIH HHS/United States
GR  - P50 AG023501/AG/NIA NIH HHS/United States
GR  - P50 AG005131/AG/NIA NIH HHS/United States
GR  - P30 AG010133/AG/NIA NIH HHS/United States
GR  - P50 AG016574/AG/NIA NIH HHS/United States
GR  - P50 AG005146/AG/NIA NIH HHS/United States
GR  - P30 AG035982/AG/NIA NIH HHS/United States
GR  - P50 AG008702/AG/NIA NIH HHS/United States
GR  - U01 AG016976/AG/NIA NIH HHS/United States
GR  - P30 AG008051/AG/NIA NIH HHS/United States
GR  - P50 AG005681/AG/NIA NIH HHS/United States
GR  - P30 AG013846/AG/NIA NIH HHS/United States
GR  - P50 AG047270/AG/NIA NIH HHS/United States
GR  - P50 AG005136/AG/NIA NIH HHS/United States
GR  - P30 AG049638/AG/NIA NIH HHS/United States
GR  - P30 AG012300/AG/NIA NIH HHS/United States
GR  - P50 AG005134/AG/NIA NIH HHS/United States
GR  - P30 AG008017/AG/NIA NIH HHS/United States
GR  - P30 AG062715/AG/NIA NIH HHS/United States
GR  - P30 AG010129/AG/NIA NIH HHS/United States
PT  - Journal Article
DEP - 20190802
PL  - United States
TA  - Alzheimers Dement (N Y)
JT  - Alzheimer's & dementia (New York, N. Y.)
JID - 101650118
PMC - PMC6690415
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - CDR
OT  - FAQ
OT  - MCID
OT  - MMSE
OT  - Meaningful decline
EDAT- 2019/08/17 06:00
MHDA- 2019/08/17 06:01
PMCR- 2019/08/02
CRDT- 2019/08/17 06:00
PHST- 2019/08/17 06:00 [entrez]
PHST- 2019/08/17 06:00 [pubmed]
PHST- 2019/08/17 06:01 [medline]
PHST- 2019/08/02 00:00 [pmc-release]
AID - S2352-8737(19)30036-8 [pii]
AID - 10.1016/j.trci.2019.06.005 [doi]
PST - epublish
SO  - Alzheimers Dement (N Y). 2019 Aug 2;5:354-363. doi: 10.1016/j.trci.2019.06.005. 
      eCollection 2019.