Background: This multicentre open-label trial examined the efficacy and safety of the traditional Japanese medicine, or Kampo medicine, yokukansan (YKS), for behavioural and psychological symptoms of dementia (BPSD) in patients with dementia with Lewy bodies. Methods: Sixty-three dementia with Lewy bodies patients with probable BPSD (M : W, 30 : 33; mean age, 78.2 1 5.8 years) were enrolled and treated with YKS for 4 weeks. Results: Significant improvements in Neuropsychiatric Inventory scores (mean decrease, 12.5 points; P < 0.001) and Zarit Burden InterviewJapanese edition tests (mean decrease, 3.6 points; P = 0.024) were observed. In patients who consented to an assessment after 2 weeks of treatment, a time-dependent significant improvement was observed in the Neuropsychiatric Inventory score (n = 23; mean decrease, 14.4; P < 0.001), each subscale, including delusions and hallucinations, the Zarit Burden Interview-Japanese edition (n = 22; mean decrease, 8.2; P < 0.01) and the behavioural pathology in Alzheimer's disease insomnia subscale. The MiniMental State Examination and the Disability Assessment for Dementia (DAD) showed no significant change. Adverse events were observed in 11 (18%) patients. Three patients (5%) discontinued YKS due to adverse reactions, namely, spasticity and exacerbation of BPSD, edema, and nausea. Hypokalaemia (<3.5 mEq/L) was present in four patients (6%) at the study endpoint. Worsening of extrapyramidal symptoms was not observed. Conclusion: YKS improved BPSD in dementia with Lewy bodies patients and caregiver burden scores without deterioration in cognitive function. YKS is useful for the treatment of delusions and hallucinations in BPSD.

Background Understanding the treatment needs of patients with dementia with Lewy bodies (DLB) is essential to develop treatment strategies. We examined the treatment needs of patients with DLB and their caregivers and the extent to which the attending physicians understand these treatment needs. Methods This was a cross-sectional, observational study conducted using questionnaires for patients, caregivers, and physicians. The study participants included patients, their caregivers, and their attending physicians who were experts in DLB. Fifty-two symptoms that are frequent and clinically important in DLB were pre-selected and classified into seven symptom domains. Treatment needs of patients and caregivers were defined as “symptom that causes them most distress,” and the frequency of each answer was tabulated. To assess the physician’s understanding of the treatment needs of patients and caregivers, patient–physician and caregiver–physician concordance rates for each answer regarding treatment needs were calculated according to symptom domains. Results In total, 263 pairs of patients–caregivers and 38 physicians were surveyed. The mean age of patients was 79.3 years, and their mean total score on the Mini-Mental State Examination was 20.9. Thirty-five and 38 symptoms were selected as symptoms causing patients and caregivers most distress, respectively. Memory impairment was most frequently selected for the treatment needs of patients, followed by constipation and bradykinesia. Memory impairment was also most frequently selected by caregivers, followed by visual hallucinations. For the symptom domain that causes patients or caregivers most distress, only about half of the patient–physician pairs (46.9%) and caregiver–physician pairs (50.8%) were matched. Logistic regression analysis identified that concordance rates for treatment needs between patient–physician and caregiver–physician were lower when autonomic dysfunction and sleep-related disorders were selected as the symptom domains that cause most distress. Conclusion There was considerable variability in the treatment needs of patients with DLB and their caregivers. Attending physicians had difficulty understanding the top treatment needs of their patients and caregivers, despite their expertise in DLB, because of various clinical manifestations. Attending physicians should pay more attention to autonomic dysfunction and sleep-related disorders in the treatment of DLB. Trial registration UMIN Clinical Trials Registry, UMIN000041844. Registered on 23 September 2020

Background: Clonazepam (CNZP) is effective in ∼90% of patients with rapid eye movement sleep behavior disorder (RBD) but has risks of oversedation, muscular relaxation, and adverse effects on cognitive function when used to treat RBD associated with dementia with Lewy bodies (DLB). Yokukansankachimpihange (YKSCH), a traditional herbal medicine, decreases sleep latency and increases sleep stage 2, like benzodiazepines (BZPs), but does not cause adverse events such as oversedation, muscular relaxation, and adverse effects on cognitive function. Given these pharmacological properties, YKSCH was studied as a potential alternative to CNZP. Methods: Of patients who were diagnosed with DLB according to the criteria for the clinical diagnosis of DLB established by the Consortium on Dementia with Lewy Bodies (CDLB) in 2017, 13 consecutive patients with the cutoff score (5 points) or more in a REM sleep behavior disorder screening questionnaire and polysomnographic evidence of REM without atonia were observed using the Neuropsychiatric Inventory (NPI) night-time behavior disturbance, visual analog scale (VAS) frequency, and VAS severity as the co-primary endpoints. Data from 11 patients who completed the study were statistically analyzed. Results: Statistically significant improvements were observed in the NPI night-time behavior disturbance, VAS frequency, and VAS severity. No notable adverse events were reported. Conclusion: The results indicated that YKSCH, which does not cause oversedation, muscular relaxation, or adverse effects on cognitive function, may provide a new therapeutic option for RBD associated with DLB as an alternative to CNZP.

(123)I-MIBG myocardial scintigraphy was superior to brain perfusion SPECT and brain MRI using an advanced statistical technique to differentiate DLB and AD.