There is an acute need for therapeutic interventions that can slow or halt the progression of Alzheimer’s disease (AD), and it is currently believed that intervention is likely necessary at a very early stage of the disease. Assessment of the patient’s experience of the subtle cognitive changes that have functional impact on daily activity may be a critical tool for measuring effects of a potential therapeutic being tested in a clinical trial. The Cognition Working Group seeks to generate evidence to support a performance-based outcome measure that improves upon the current measurement of mild levels of cognitive impairment (MCI) due AD, as well as that captures the patient’s perspective on relevant outcomes that would contribute to detection of disease, description of disease progression, and the measurement of treatment effect. This measure would be used to support labeling claims of new AD therapies.
Development of a patient-reported outcome (PRO) instrument to assess complex activities of daily living and interpersonal functioning in patients with mild cognitive impairment due to suspected Alzheimer’s disease: the qualitative research phase
Gordon MF, Duhig A, Chandler J, Piault E, Frank L, Lenderking W, on behalf of the Patient-Reported Outcome Consortium’s Cognition Working Group. Development of a patient-reported outcome (PRO) instrument to assess complex activities of daily living and interpersonal functioning in patients with mild cognitive impairment due to suspected Alzheimer’s disease: the qualitative research phase. American Academy of Neurology’s (AAN) 65th Annual Meeting; 2013 Mar 16; San Diego, CA USA.
Miller D, Frank L, Doody R, Leibman C, Lenderking W. Measuring the Earliest Symptoms of Mild Cognitive Impairment. Clinical Trials on Alzheimer’s disease (CTAD) Fourth Conference; 2011 Nov 3; San Diego, CA USA.
Working Group Sponsors
AstraZeneca Pharmaceuticals LP
Boehringer Ingelheim Pharmaceuticals, Inc.
Eli Lilly and Company
Merck, Sharp & Dohme Corp.
Novartis Pharmaceutical Corporation