Trial reportInternational psychogeriatrics2015
Change in agitation in Alzheimer's disease in the placebo arm of a nine-week controlled trial.
Trial report in International psychogeriatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- Quantifying placebo responses in clinical evaluation of neuropsychiatric symptoms in Alzheimer's disease.European journal of clinical pharmacology · 2019Pooled it
- Standardizing care for agitation in Alzheimer's disease, results from a randomized controlled trial of an integrated care pathway versus usual care - the StaN trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Trial
- Escitalopram for agitation in Alzheimer's dementia: a randomized controlled phase 3 trial.Nature medicine · 2025Trial
- Clinical trials for neuropsychiatric syndromes in major and mild neurocognitive disorders: A CONSORT-based approach.International psychogeriatrics · 2025Review
- Psychosis as a Treatment Target in Dementia: A Roadmap for Designing Interventions.Journal of Alzheimer's disease : JAD · 2022Review
- Effects of rich cannabidiol oil on behavioral disturbances in patients with dementia: A placebo controlled randomized clinical trial.Frontiers in medicine · 2022Article
- Agitation in Alzheimer's disease: Novel outcome measures reflecting the International Psychogeriatric Association (IPA) agitation criteria.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2021Article
- New approaches to symptomatic treatments for Alzheimer's disease.Molecular neurodegeneration · 2021Review
- Alzheimer's disease drug development pipeline: 2021.Alzheimer's & dementia (New York, N. Y.) · 2021Article
- Agitation and impulsivity in mid and late life as possible risk markers for incident dementia.Alzheimer's & dementia (New York, N. Y.) · 2020Review
- Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2019Article
- Article
- Antipsychotics for agitation in dementia.Canadian family physician Medecin de famille canadien · 2018Article
- A Literature Review of Methodologies Used in Randomized Clinical Trials of Agitation in Alzheimer's Disease.The journal of prevention of Alzheimer's disease · 2018Review
- The need for harmonisation and innovation of neuropsychological assessment in neurodegenerative dementias in Europe: consensus document of the Joint Program for Neurodegenerative Diseases Working Group.Alzheimer's research & therapy · 2017Review
- Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease with a Cannabis-Based Magistral Formulation: An Open-Label Prospective Cohort Study.Medical cannabis and cannabinoidsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 11 institutions in 2 countries.
Funding
Abstract
backgroundPlacebo 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).
methodsIn 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.
resultsAgitation 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.
conclusionsWe 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.