The DOI matches its Crossref record; 38 of the 38 references it cites were found in a registry or an index.
Treatment of agitation in AD: A randomized, placebo-controlled clinical trial
Abstract
BACKGROUND: Treatment of agitation is a crucial problem in the care of patients with AD. Although antipsychotic and antidepressant medications and behavior management techniques (BMT) have each been used to treat agitation, clinical trials of these treatments have been characterized by small sample sizes and uncontrolled treatment designs. OBJECTIVE: To compare haloperidol, trazodone, and BMT with placebo in the treatment of agitation in AD outpatients. METHODS: A total of 149 patients with AD and their caregivers participated in a randomized, placebo-controlled, multicenter trial. Blind assessment was conducted at baseline and after 16 weeks of treatment. The three active treatments were haloperidol, trazodone, and BMT. The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change was the primary outcome measure. Secondary outcomes included patient agitation, cognition, and function, and caregiver burden. RESULTS: Thirty-four percent of subjects improved relative to baseline. No significant differences on outcome were obtained between haloperidol (mean dose, 1.8 mg/d), trazodone (mean dose, 200 mg/d), BMT, or placebo. Significantly fewer adverse events of bradykinesia and parkinsonian gait were evident in the BMT arm. No other significant difference in adverse events was seen. Symptoms did not respond differentially to the different treatments. CONCLUSIONS: Comparable modest reductions in agitation occurred in patients receiving haloperidol, trazodone, BMT, and placebo. More effective pharmacologic, nonpharmacologic, and combination treatments are needed.
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In the citing paper
“The two RCTs of aromatherapy both took place in care homes. 43,44”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [43]
In the citing paper
“This suggests that training paid caregivers in communication, person-centred care skills or dementia care mapping are clinically important interventions”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [43]
In the citing paper
“The other, non-blinded, study found significant improvement compared with the control group. 43”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [43]
In the citing paper
“but some reported a significant decline on the MMSE scores in antidepressant users [43, 48].”
From Antidepressant use and cognitive decline in patients with dementia: a national cohort study (2025) · cites this paper as [48]
In the citing paper
“Previous studies of antidepressant use and cognitive decline in people with dementia have shown mixed findings.”
From Antidepressant use and cognitive decline in patients with dementia: a national cohort study (2025) · cites this paper as [48]
In the citing paper
“In the first, trazodone showed no significant benefit over placebo or behavior management therapy (BMT) for agitation, and post hoc analysis suggested greater cognitive decline with trazodone. 31”
From Critical evaluation of real‐world evidence of repurposable medicines in the Alzheimer's disease drug development pipeline using a target trial emulation (2026) · cites this paper as [31]
In the citing paper
“In the first, trazodone showed no significant benefit over placebo or behavior management therapy (BMT) for agitation, and post hoc analysis suggested greater cognitive decline with trazodone. 31”
From Critical evaluation of real‐world evidence of repurposable medicines in the Alzheimer's disease drug development pipeline using a target trial emulation (2026) · cites this paper as [31]
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Vickrey, B. G., Mittman, B. S., Connor, K. I., Pearson, M. L., Della Penna, R. D., Ganiats, T. G., DeMonte, R. W., Chodosh, J., Cui, X., Vassar, S., et al. (2006) · Annals of Internal Medicine · doi:10.7326/0003-4819-145-10-200611210-00004 · Cited by 44
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Metadata
- Authors
- Teri, L., Logsdon, R. G., Peskind, E., Raskind, M., Weiner, M. F., Tractenberg, R. E., Foster, N. L., Schneider, L. S., Sano, M., Whitehouse, P., Tariot, P., Mellow, A. M., Auchus, A. P., Grundman, M., Thomas, R. G., Schafer, K., & Thal, L. J.
- Affiliations
- University of Southern California (US)
- ORCID
- Venue
- Neurology
- Published
- 2000-11-14
- Volume
- 55
- Issue
- 9
- Pages
- 1271-1278
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- OpenAlex
- W1990805071
- Cited by
- 330
- References
- 36
- Citations by year
- 2026: 6 · 2025: 8 · 2024: 7 · 2023: 2 · 2022: 34 · 2021: 12 · 2020: 7 · 2019: 7 · 2018: 8 · 2017: 4 · 2016: 12 · 2015: 11 · 2014: 11 · 2013: 8 · 2012: 11
- FWCI
- 11.70
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Neurology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Aging (AG 010483, U19AG010483)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- Alzheimer's disease, agitation, haloperidol, trazodone, behavior management strategies, antipsychotic drugs, antidepressants, caregiver burden, bradykinesia, parkinsonian gait, non-pharmacological treatment, outpatients
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Behavior Therapy, Double-Blind Method, Female, Haloperidol, Humans, Male, Psychomotor Agitation, Trazodone
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