ArticleDementia and geriatric cognitive disorders2017
Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated with Dementia with Lewy Bodies: A Pilot Study.
Article in Dementia and geriatric cognitive disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses 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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Sleep disturbances in Lewy body dementia: A systematic review.International journal of geriatric psychiatry · 2022Pooled it
- Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021Pooled it
- Lewy body dementia: exploring biomarkers and pathogenic interactions of amyloid β, tau, and α-synuclein.Molecular neurodegeneration · 2025Review
- Research on the perspectives of people affected by dementia with Lewy bodies: a scoping review.Alzheimer's research & therapy · 2025Article
- α-Synuclein triggers cofilin pathology and dendritic spine impairment via a PrPCell death & disease · 2024Article
- Patient- and proxy-reported quality of life in advanced dementia with Lewy bodies.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Article
- Insights into the management of Lewy body dementia: a scoping review.Annals of medicine and surgery (2012) · 2024Article
- Armodafinil as a Potential Pharmacological Treatment for Attention Deficit Hyperactivity Disorder in Adults: A Review.Current neuropharmacology · 2024Review
- Biomedical knowledge graph learning for drug repurposing by extending guilt-by-association to multiple layers.Nature communications · 2023Article
- Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations.Translational neurodegeneration · 2022Review
- Case Study 3: A 58-Year-Old Woman Referred for Evaluation of Suspected Alzheimer Dementia.The Journal of neuropsychiatry and clinical neurosciences · 2022Article
- Advances in dementia with Lewy bodies.Therapeutic advances in neurological disorders · 2021Review
- Challenges and opportunities for improving the landscape for Lewy body dementia clinical trials.Alzheimer's research & therapy · 2020Review
- New evidence on the management of Lewy body dementia.The Lancet. Neurology · 2020Review
- Clinical drug development for dementia with Lewy bodies: past and present.Expert opinion on investigational drugs · 2019Review
- Excessive Daytime Sleepiness in Major Dementia Syndromes.American journal of Alzheimer's disease and other dementias · 2019Article
- Novel Treatment Opportunities Against Cognitive Impairment in Parkinson's Disease with an Emphasis on Diabetes-Related Pathways.CNS drugs · 2019Review
- A Review of Dementia with Lewy Bodies' Impact, Diagnostic Criteria and Treatment.Neurology and therapy · 2018Review
- Quality of Life in Patients with Dementia with Lewy Bodies.Behavioural neurology · 2018Review
- REM Sleep Behavior Disorder (RBD) in Dementia with Lewy Bodies (DLB).Behavioural neurology · 2018Review
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
BACKGROUND/
aimsHypersomnia is common in dementia with Lewy bodies (DLB). We assessed the efficacy, safety, and tolerability of armodafinil for hypersomnia associated with DLB.
methodsWe performed a 12-week pilot trial of armodafinil therapy (125-250 mg orally daily) in DLB outpatients with hypersomnia. The patients underwent neurologic examinations, a neuropsychological battery, laboratory testing, electrocardiography, and polysomnography. Efficacy was assessed at 2, 4, 8, and 12 weeks. Safety assessment included laboratory examinations, QTc interval, and heart rate. Tolerability was assessed by analysis of adverse events. Data were analyzed using the last-observation-carried-forward method.
resultsOf 20 participants, 17 completed the protocol. The median age was 72 years, most of the participants were men (80%), and most had spouses as caregivers. The Epworth Sleepiness Scale (p < 0.001), Maintenance of Wakefulness Test (p = 0.003), and Clinical Global Impression of Change (p < 0.001) scores improved at week 12. The Neuropsychiatric Inventory total score (p = 0.003), visual hallucinations (p = 0.003), and agitation (p = 0.02) improved at week 4. Caregiver overall quality of life improved at week 12 (p = 0.004). No adverse events occurred.
conclusionThese pilot data suggest improvements in hypersomnia and wakefulness and reasonable safety and tolerability of armodafinil therapy in hypersomnolent patients with DLB. Our findings inform the use of pharmacologic strategies for managing hypersomnolence in these patients.
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Registered trials
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.