Agitation in Alzheimer's disease: Novel outcome measures reflecting the International Psychogeriatric Association (IPA) agitation criteria. Issue 10 (16th June 2021)

• Record Type: Journal Article
• Authors: De Mauleon, Adelaide; Ismail, Zahinoor; Rosenberg, Paul; Miller, David; Cantet, Christelle; O'Gorman, Cedric; Vellas, Bruno; Lyketsos, Constantine; Soto, Maria
• Is Part Of: Alzheimer's & dementia. Volume 17:Issue 10(2021)
• Page Start: 1687
• Page End: 1697
• Publication Date: 2021-06-16
• Subjects: aggression -- agitation -- Alzheimer's disease -- dementia -- efficacy -- gold standard -- measure -- neuropsychiatric symptoms -- outcome -- research -- scales -- trials -- validation; Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.12335
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Introduction: The 2017 European Union‐North American Clinical Trials in Alzheimer's Disease Task Force recommended development of clinician‐rated primary outcome measures for Alzheimer's disease (AD) agitation trials, incorporating International Psychogeriatric Association (IPA) criteria. Methods: In a modified Delphi process, Cohen‐Mansfield Agitation Inventory (CMAI) and Neuropsychiatric Inventory‐Clinician (NPI‐C) items were mapped to IPA agitation domains generating novel instruments, CMAI‐IPA and NPI‐C‐IPA. Validation in the Agitation and Aggression AD Cohort (A3C) assessed minimal clinically important differences (MCIDs), change sensitivity, and predictive validity. Results: MCID was –17 (odds ratio [OR] = 14.9, 95% confidence interval [CI] = 6.8–32.6) for CMAI; –5 (OR = 9.3, 95% CI = 4.0–21.2) for CMAI‐IPA; –3 (OR = 11.9, 95% CI = 4.1–34.8) for NPI‐C‐A+A; and –5 (OR = 7.8, 95% CI = 3.4–17.9) for NPI‐C‐IPA at 3 months. Areas under the curve suggested no scale better predicted global clinician ratings. Sensitivity to change for all measures was high. Conclusion: Internal consistency and reliability analyses demonstrated better accuracy for the NPI‐C‐IPA than for the CMAI‐IPA and can be used for agitation clinical trial inclusion, and for response to intervention.