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Trial Information
Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaNervous SystemProduct ClassPsycholepticsPharmacological SubgroupAntipsychoticsChemical SubgroupOther AntipsychoticsCondition StudiedAlzheimer Disease
Sponsor Protocol NumberRIS-INT-83Enrollment18Data PartnerJohnson & Johnson% Female72.2%Mean/Median Age (Years)85.0% White94.4%
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2025-0352 : ALL-EMBRACED: clinicAL triaLs web-sErvice to Modify eligiBility cRiteria and pre-screening viA artifiCial intElligence methoDs
- 2025-0168 : Analysis or Predictors of Treatment-Emergent CVAE and other Side Effects during Risperidone Use in Dementia
- 2024-0492 : Predicting individual risks and benefits of antipsychotic treatment in people living with dementia
- 2023-5295 : Individual-level and study-level predictors of neuropsychiatric symptom placebo response in Alzheimer's Disease clinical trials
- 2022-4992 : Temporal trajectories of side-effects associated with antipsychotic treatment: An individual participant data meta-analysis
- 2021-4575 : A Novel Method to Summarize Safety in Clinical Trials Using Pharmacological Class-Related Risks in FAERS
- 2016-0880 : Incidence of death and other SAEs related to second generation antipsychotic or placebo treatment in RCTs - a systematic review and meta-analysis