Change in agitation in Alzheimer's disease in the placebo arm of a nine-week controlled trial
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BACKGROUND: Placebo responses raise significant challenges for the design of clinical trials. We report changes in agitation outcomes in the placebo arm of a recent trial of citalopram for agitation in Alzheimer's disease (CitAD). METHODS: In the CitAD study, all participants and caregivers received a psychosocial intervention and 92 were assigned to placebo for nine weeks. Outcomes included Neurobehavioral Rating Scale agitation subscale (NBRS-A), modified AD Cooperative Study-Clinical Global Impression of Change (CGIC), Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory (NPI) Agitation/Aggression domain (NPI A/A) and Total (NPI-Total) and ADLs. Continuous outcomes were analyzed with mixed-effects modeling and dichotomous outcomes with logistic regression. RESULTS: Agitation outcomes improved over nine weeks: NBRS-A mean (SD) decreased from 7.8 (3.0) at baseline to 5.4 (3.2), CMAI from 28.7 (6.7) to 26.7 (7.4), NPI A/A from 8.0 (2.4) to 4.9 (3.8), and NPI-Total from 37.3 (17.7) to 28.4 (22.1). The proportion of CGI-C agitation responders ranged from 21 to 29% and was significantly different from zero. MMSE improved from 14.4 (6.9) to 15.7 (7.2) and ADLs similarly improved. Most of the improvement was observed by three weeks and was sustained through nine weeks. The major predictor of improvement in each agitation measure was a higher baseline score in that measure. CONCLUSIONS: We observed significant placebo response which may be due to regression to the mean, response to a psychosocial intervention, natural course of symptoms, or nonspecific benefits of participation in a trial.
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Lack of diagnostic precision in these trials may contribute to commonly observed challenges including robust placebo responses and failure of placebo groups to decline.
“Lack of diagnostic precision in these trials may contribute to commonly observed challenges including robust placebo responses and failure of placebo groups to decline. 24 , 25”
From Alzheimer’s disease drug development pipeline: 2021 (2021) · cites this paper as [25]
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- Authors
- Rosenberg, P. B., Drye, L. T., Porsteinsson, A. P., Pollock, B. G., Devanand, D. P., Frangakis, C., Ismail, Z., Marano, C., Meinert, C. L., Mintzer, J. E., Munro, C. A., Pelton, G., Rabins, P. V., Schneider, L. S., Shade, D. M., Weintraub, D., Newell, J., Yesavage, J., & Lyketsos, C. G.
- Affiliations
- Johns Hopkins University (US)
- University of Rochester Medicine (US)
- Centre for Addiction and Mental Health (CA)
- Columbia University (US)
- University of Calgary (CA)
- Medical University of South Carolina (US)
- University of Southern California (US)
- Mental Illness Research, Education and Clinical Centers (US)
- VA Palo Alto Health Care System (US)
- Corresponding author
- Rosenberg, Paul B.
- ORCID
- Venue
- International Psychogeriatrics
- Publisher
- Elsevier BV
- Published
- 2015-12
- Volume
- 27
- Issue
- 12
- Pages
- 2059-2067
- ISSN
- 1041-6102 (ISSN-L)
- PMC
- PMC4669064
- OpenAlex
- W2395421378
- Cited by
- 28
- References
- 43
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2022: 5 · 2021: 4 · 2020: 1 · 2019: 3 · 2018: 3 · 2017: 3 · 2016: 3
- FWCI
- 2.43
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- International Psychogeriatrics (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (P50, AG05142)
- National Institute on Aging
- National Institute of Mental Health (R01AG031348)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Keywords
- Alzheimer's disease, agitation, placebo response, citalopram, regression to the mean, psychosocial interventions, neuropsychiatric symptoms, activities of daily living, clinical trial design
- MeSH terms
- Activities of Daily Living, Aged, Aged, 80 and over, Aggression, Alzheimer Disease, Double-Blind Method, Female, Humans, Male, Psychiatric Status Rating Scales, Psychomotor Agitation, Severity of Illness Index, Citalopram, Placebo Effect, Treatment Outcome, Caregivers, Antidepressive Agents, Second-Generation
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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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