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@ARTICLE{Scuteri:271342,
      author       = {Scuteri, Damiana and Pagliaro, Martina and Mantia, Isabel
                      and Contrada, Marianna and Pignolo, Loris and Tonin, Paolo
                      and Nicotera, Pierluigi and Bagetta, Giacinto and
                      Corasaniti, Maria Tiziana},
      collaboration = {investigators, Pilot BRAINAID Trial},
      title        = {{E}fficacy of therapeutic intervention with {N}ano{BEO} to
                      manage agitation and pain in patients suffering from severe
                      dementia: a pilot clinical trial.},
      journal      = {Frontiers in pharmacology},
      volume       = {15},
      issn         = {1663-9812},
      address      = {Lausanne},
      publisher    = {Frontiers Media},
      reportid     = {DZNE-2024-01043},
      pages        = {1417851},
      year         = {2024},
      abstract     = {An estimated 57.4 million people live with dementia
                      worldwide, with the social burden of the disease steadily
                      growing. Despite the approval of lecanemab and ongoing
                      trials, there is still a lack of effective and safe
                      treatments for behavioral and psychological symptoms of
                      dementia (BPSD), which affect $99\%$ of patients. Agitation
                      is one of the most disabling BPSD, with a cross-sectional
                      prevalence of $≥50\%$ in nursing homes, and refers to
                      help-seeking behavior in response to various sources of
                      discomfort, among which pain is a crucial component.This
                      pilot phase of the BRAINAID (NCT04321889) trial aimed to
                      assess the effectiveness of the patented nanotechnological
                      device NanoBEO in older (≥65 years) people with severe
                      dementia. This randomized placebo-controlled trial, with
                      quadruple masking that involved all operators and
                      participants, followed the SPIRIT and CONSORT statements. A
                      total of 29 patients completed the trial. The patients were
                      randomly allocated in a 1:1 ratio to the NanoBEO or placebo
                      group, and the corresponding product was applied on both
                      arms once daily for 4 weeks, with a 4-week follow-up period.
                      The primary endpoint was efficacy against agitation. The
                      secondary endpoints were efficacy against agitation at
                      follow-up and efficacy against pain. Any adverse events were
                      reported, and biochemical analyses were performed.The
                      NanoBEO intervention reduced the frequency $(28\%)$ and
                      level of disruptiveness of agitated behaviors. The effect on
                      frequency was statistically significant after 2 weeks of
                      treatment. The efficacy of NanoBEO on agitated behaviors
                      lasted for the entire 4-week treatment period. No additional
                      psychotropic drugs were prescribed throughout the study
                      duration. The results after 1 week of treatment demonstrated
                      that NanoBEO had statistically significant analgesic
                      efficacy $(45.46\%$ improvement in pain intensity). The
                      treatment was well tolerated.This trial investigated the
                      efficacy of NanoBEO therapy in managing agitation and pain
                      in dementia. No need for rescue medications was recorded,
                      strengthening the efficacy of NanoBEO in prolonged therapy
                      for advanced-stage dementia and the usefulness of the
                      intervention in the deprescription of potentially harmful
                      drugs. This study provided a robust rationale for the
                      application of NanoBEO in a subsequent large-scale pivotal
                      trial to allow clinical translation of the product. Clinical
                      Trial Registration: ClinicalTrials.gov, identifier
                      NCT04321889.},
      keywords     = {BRAINAID (Other) / NCT04321889 (Other) / NanoBEO (Other) /
                      agitation (Other) / behavioural and psychological symptoms
                      of dementia (Other) / dementia (Other) / pain (Other) /
                      pilot clinical trial (Other)},
      cin          = {AG Bano},
      ddc          = {610},
      cid          = {I:(DE-2719)1013003},
      pnm          = {351 - Brain Function (POF4-351)},
      pid          = {G:(DE-HGF)POF4-351},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39148533},
      pmc          = {pmc:PMC11325727},
      doi          = {10.3389/fphar.2024.1417851},
      url          = {https://pub.dzne.de/record/271342},
}