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Trial Information
Generic NameRisperidoneProduct NameRISPERDAL®Therapeutic AreaBehaviors and Mental DisordersEnrollment626% Female67.8%% White88%
Product ClassAtypical AntipsychoticsSponsor Protocol NumberRIS-USA-63/CR006022Data PartnerJohnson & JohnsonCondition StudiedDementiaMean/Median Age (Years)82.7
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
- 2024-0944 : Mediators of Mortality Risk in Older Adults with Dementia: Analysis of Multiple Pathways Using Risperidone Trial
- 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
- 2022-5105 : Symptom severity and minimal clinically important differences for agitation outcome scores in Alzheimer's disease clinical trials
- 2022-5091 : Consistency checks to improve measurement with the Cohen Mansfield Agitation Inventory (CMAI)
- 2022-4992 : Temporal trajectories of side-effects associated with antipsychotic treatment ? An individual participant data meta-analysis
- 2021-4683 : The effects of systemic anti-infective concomitant medications on progression of neurological diseases
- 2021-4575 : A NOVEL METHOD TO SUMMARIZE SAFETY IN CLINICAL TRIALS USING PHARMACOLOGICAL CLASS-RELATED RISKS IN FAERS
- 2020-4305 : A predictive model to guide safer risperidone prescribing in people with Alzheimer?s disease
- 2016-0969 : Identifying individual factors predictive of extrapyramidal side effects (EPS) in Alzheimer's disease
- 2016-0880 : Incidence of death and other SAEs related to second generation antipsychotic or placebo treatment in RCTs - a systematic review and meta-analysis