Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations

被引：7

作者：

Rodriguez-Porcel, Federico ^{[1
]}

Wyman-Chick, Kathryn A. ^{[2
]}

Abdelnour Ruiz, Carla ^{[3
]}

Toledo, Jon B. ^{[4
]}

Ferreira, Daniel ^{[5
,6
]}

Urwyler, Prabitha ^{[7
]}

Weil, Rimona S. ^{[8
]}

Kane, Joseph ^{[9
]}

Pilotto, Andrea ^{[10
]}

Rongve, Arvid ^{[11
,12
]}

Boeve, Bradley ^{[13
]}

Taylor, John-Paul ^{[14
]}

McKeith, Ian ^{[14
]}

Aarsland, Dag ^{[15
]}

Lewis, Simon J. G. ^{[16
]}

机构：

[1] Med Univ South Carolina, Dept Neurol, 208b Rutledge Av, Charleston, SC 29403 USA

[2] HealthPartners, Ctr Memory & Aging, Dept Neurol, St Paul, MN USA

[3] Autonomous Univ Barcelona, Barcelona, Spain

[4] Univ Florida, Fixel Inst Neurol Dis, Gainesville, FL USA

[5] Karolinska Inst, Ctr Alzheimers Res, Dept Neurobiol Care Sci & Soc, Div Clin Geriatr, Stockholm, Sweden

[6] Mayo Clin, Dept Radiol, Rochester, MN USA

[7] Univ Bern, ARTORG Ctr Biomed Engn Res, Bern, Switzerland

[8] UCL, Dementia Res Ctr, London, England

[9] Queens Univ, Ctr Publ Hlth, Belfast, Antrim, North Ireland

[10] Univ Brescia, Dept Clin & Expt Sci, Neurol Unit, Brescia, Italy

[11] Haugesund Hosp, Helse Fonna, Dept Res & Innovat, Haugesund, Norway

[12] Univ Bergen, Inst Clin Med K1, Bergen, Norway

[13] Mayo Clin, Ctr Sleep Med, Dept Neurol, Rochester, MN USA

[14] Newcastle Univ, Translat & Clin Res Inst, Newcastle Upon Tyne, Tyne & Wear, England

[15] Kings Coll London, Inst Psychiat Psychol & Neurosci, Dept Old Age Psychiat, London, England

[16] Univ Sydney, Sch Med Sci, Brain & Mind Ctr, ForeFront Parkinsons Dis Res Clin, 100 Mallett St, Camperdown, NSW 2050, Australia

来源：

TRANSLATIONAL NEURODEGENERATION | 2022年 / 11卷 / 01期

基金：

英国医学研究理事会;

关键词：

Dementia with Lewy bodies; Clinical trials; Outcomes; Measurement properties; SLEEP BEHAVIOR DISORDER; PARKINSONS-DISEASE DEMENTIA; MINI-MENTAL-STATE; MONTREAL COGNITIVE ASSESSMENT; RATING-SCALE SUM; OPEN-LABEL TRIAL; ALZHEIMERS-DISEASE; VISUAL HALLUCINATIONS; NEUROPSYCHIATRIC INVENTORY; DOUBLE-BLIND;

D O I：

10.1186/s40035-022-00299-w

中图分类号：

Q189 [神经科学];

学科分类号：

071006 ;

摘要：

The selection of appropriate outcome measures is fundamental to the design of any successful clinical trial. Although dementia with Lewy bodies (DLB) is one of the most common neurodegenerative conditions, assessment of therapeutic benefit in clinical trials often relies on tools developed for other conditions, such as Alzheimer's or Parkinson's disease. These may not be sufficiently valid or sensitive to treatment changes in DLB, decreasing their utility. In this review, we discuss the limitations and strengths of selected available tools used to measure DLB-associated outcomes in clinical trials and highlight the potential roles for more specific objective measures. We emphasize that the existing outcome measures require validation in the DLB population and that DLB-specific outcomes need to be developed. Finally, we highlight how the selection of outcome measures may vary between symptomatic and disease-modifying therapy trials.

引用

页数：18

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