Dataset Information

Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses.

ABSTRACT:

Objectives

The effects of masupirdine on the neuropsychiatric symptoms were explored.

Methods

Masupirdine (SUVN-502) was evaluated for its effects on cognition in patients with moderate AD. The prespecified primary outcome showed no drug-placebo difference. Post hoc analyses of domains of the 12-item neuropsychiatric inventory scale were carried out.

Results

In a subgroup of patients (placebo, n = 57; masupirdine 50 mg, n = 53; masupirdine 100 mg, n = 48) with baseline agitation/aggression symptoms ≥1, a statistically significant reduction in agitation/aggression scores was observed in masupirdine 50 mg (95% confidence interval (CI), -1.9 to -0.5, p < 0.001) and masupirdine 100 mg (95% CI, -1.7 to -0.3, p = 0.007) treated arms at Week 13 in comparison to placebo and the effect was sustained for trial duration of 26 weeks in the masupirdine 50 mg treatment arm (95% CI, -2.3 to -0.8, p < 0.001). Similar observations were noted in the subgroup of patients (placebo, n = 29; masupirdine 50 mg, n = 30; masupirdine 100 mg, n = 21) with baseline agitation/aggression symptoms ≥3. In the subgroup of patients (placebo, n = 28; masupirdine 50 mg, n = 28; masupirdine 100 mg, n = 28) who had baseline psychosis symptoms and/or symptom emergence, a significant reduction in psychosis scores was observed in the masupirdine 50 mg (Week 4: 95% CI, -2.8 to -1.4, p < 0.001; Week 13: 95% CI, -3.3 to -1.3, p < 0.001) and masupirdine 100 mg (Week 4: 95% CI, -1.4 to 0, p = 0.046; Week 13: 95% CI, -1.9 to 0.1, p = 0.073) treatment arms in comparison to placebo.

Conclusion

Further research is warranted to explore the potential beneficial effects of masupirdine on NPS.

SUBMITTER: Nirogi R

PROVIDER: S-EPMC9828442 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses.

Nirogi Ramakrishna R Jayarajan Pradeep P Benade Vijay V Shinde Anil A Goyal Vinod Kumar VK Jetta Satish S Ravula Jyothsna J Abraham Renny R Grandhi Venkata Ramalingayya VR Subramanian Ramkumar R Pandey Santosh Kumar SK Badange Rajesh Kumar RK Mohammed Abdul Rasheed AR Jasti Venkat V Ballard Clive C Cummings Jeffrey J

International journal of geriatric psychiatry 20221001 10

<h4>Objectives</h4>The effects of masupirdine on the neuropsychiatric symptoms were explored.<h4>Methods</h4>Masupirdine (SUVN-502) was evaluated for its effects on cognition in patients with moderate AD. The prespecified primary outcome showed no drug-placebo difference. Post hoc analyses of domains of the 12-item neuropsychiatric inventory scale were carried out.<h4>Results</h4>In a subgroup of patients (placebo, n = 57; masupirdine 50 mg, n = 53; masupirdine 100 mg, n = 48) with baseline agit ...[more]

PMID: 36168659

Similar Datasets

Project description:IntroductionIndividuals with psychosis may access emergency services due to aggression and agitation. When the de-escalation technique fails to achieve tranquillisation, several pharmacological options are available. However, evidence on which intervention to prefer in terms of efficacy and tolerability to achieve resolution of the acute episode (ie, rapid tranquillisation) of aggression and agitation is currently fragmentary.Methods and analysisWe will include all randomised controlled trials comparing drugs or drug combinations or placebo for aggression or agitation episodes in adult individuals with psychosis. We will include individuals with psychosis (eg, schizophrenia and related disorders, bipolar disorder with psychotic symptoms, psychotic depression) but not substance or medication-induced psychosis or psychosis due to another medical condition. Our primary outcomes are the change in aggression or agitation scores within few hours since the administration of the intervention (efficacy outcome) and the proportion of participants who dropped out due to adverse effects (tolerability outcome). We will retrieve relevant studies from the register of studies of the Cochrane Schizophrenia Group. Also, we will run additional searches on CENTRAL, Embase and PubMed to retrieve potentially eligible studies focusing on other psychiatric diagnoses than those in the schizophrenia spectrum. We will conduct a random-effects network meta-analysis (NMA) for primary and secondary outcomes. In case of rare events of dichotomous outcomes, a common-effect Mantel-Haenszel NMA will be used instead. We will use the surface under the cumulative ranking curve and the mean ranks to rank all available treatments. Local and global methods of evaluation of inconsistency will be employed. Quality of evidence contributing to network estimates of the main outcomes will also be assessed with Confidence in Network Meta-Analysis.Ethics and disseminationThis study does not require ethical approval. We will disseminate our findings by publishing results in a peer-reviewed journal.Prospero registration numberCRD42019137945.

Project description:BackgroundThe purpose of this study is to identify factors that predict nursing home placement among community-dwelling Alzheimer's disease (AD) patients with psychosis and/or agitation in a randomized clinical trial (ClinicalTrials.gov number, NCT00015548).Methods418 participants with AD enrolled in the Clinical Antipsychotic Trial of Intervention Effectiveness - AD (CATIE-AD) trial of anti-psychotic medications and having no evidence of nursing home use at baseline were followed at 9 months post-random assignment using data provided by caregiver proxy. χ2 tests, t-tests and Cox proportional hazard modeling were used to examine the baseline correlates of nursing home use.ResultsOf outpatients with no prior nursing home use, 15% were placed in a nursing home in the 9 months following baseline, with the average time to placement being 122 days. Bivariate analyses indicate that those with prior outpatient mental health use at study entry were more likely to be admitted; so too were those with worse physical functioning - i.e. lower scores on the AD Cooperative Study Activities of Daily Living Scale (ADCS-ADL), lower utility scores on the Health Utility Index (HUI)-III, and worse cognition on the Mini-mental State Examination. Controlling for other factors, non-Hispanic white race (hazard ratio [HR] = 2.16) and prior mental health use (HR = 1.87) increased the likelihood of admission. Those with higher ADCS-ADL scores were less likely to be placed (HR = 0.97).ConclusionsFactors leading to nursing home entry among psychotic/agitated AD patients are similar to the general population, though high incidence of nursing home entry highlights the importance of accounting for such utilization in health economic studies of AD outcomes. It also highlights the importance of using information on ADLs and other characteristics to develop profiles identifying those at greater or lesser risk of nursing home entry and, in so doing, inform population planning associated with AD and identification of those patients and caregivers who might benefit most from interventions to prevent eventual placement.

Dataset Information

Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses.

Objectives

Methods

Results

Conclusion

Publications

Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets