TY - JOUR
T1 - Apathy in Neurodegenerative Diseases
T2 - Recommendations on the Design of Clinical Trials
AU - Cummings, Jeffrey
AU - Friedman, Joseph H.
AU - Garibaldi, George
AU - Jones, Martin
AU - Macfadden, Wayne
AU - Marsh, Laura
AU - Robert, Philippe H.
PY - 2015/9/24
Y1 - 2015/9/24
N2 - Apathy is a common feature of neurodegenerative disorders but is difficult to study in a clinical trial setting due to practical and conceptual barriers. Principal challenges include a paucity of data regarding apathy in these disorders, an absence of established diagnostic criteria, the presence of confounding factors (eg, coexisting depression), use of concomitant medications, and an absence of a gold-standard apathy assessment scale. Based on a literature search and ongoing collaboration among the authors, we present recommendations for the design of future clinical trials of apathy, suggesting Alzheimer disease and Parkinson disease as models with relevance across a wider array of neuropsychiatric disorders. Recommendations address clarification of the targeted study population (apathy diagnosis and severity at baseline), confounding factors (mood/cognition, behavior, and treatment), outcome measures, study duration, use of comparators and considerations around environment, and the role of the caregiver and patient assent. This review contributes to the search for an optimal approach to study treatment of apathy in neuropsychiatric disorders.
AB - Apathy is a common feature of neurodegenerative disorders but is difficult to study in a clinical trial setting due to practical and conceptual barriers. Principal challenges include a paucity of data regarding apathy in these disorders, an absence of established diagnostic criteria, the presence of confounding factors (eg, coexisting depression), use of concomitant medications, and an absence of a gold-standard apathy assessment scale. Based on a literature search and ongoing collaboration among the authors, we present recommendations for the design of future clinical trials of apathy, suggesting Alzheimer disease and Parkinson disease as models with relevance across a wider array of neuropsychiatric disorders. Recommendations address clarification of the targeted study population (apathy diagnosis and severity at baseline), confounding factors (mood/cognition, behavior, and treatment), outcome measures, study duration, use of comparators and considerations around environment, and the role of the caregiver and patient assent. This review contributes to the search for an optimal approach to study treatment of apathy in neuropsychiatric disorders.
KW - Alzheimer disease
KW - apathy
KW - Parkinson disease
KW - trial design
UR - http://www.scopus.com/inward/record.url?scp=84940207542&partnerID=8YFLogxK
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U2 - 10.1177/0891988715573534
DO - 10.1177/0891988715573534
M3 - Article
C2 - 25809634
AN - SCOPUS:84940207542
SN - 0891-9887
VL - 28
SP - 159
EP - 173
JO - Journal of Geriatric Psychiatry and Neurology
JF - Journal of Geriatric Psychiatry and Neurology
IS - 3
ER -