Trial intelligence / Profile preview

TAP/DAP: Quetiapine for Agitation/Psychosis in Dementia/Parkinsonism

NCT00043849Phase 4

Key facts

Status
Completed
Start
Jul 2002
Primary completion
Jun 2005
Countries
1
Sponsor
National Institute on Aging
Modality
Small Molecules
Conditions
psychosisagitation
01

Overview

Phase 4, randomised, double-blind trial in psychosis and agitation comparing Quetiapine with Placebo (2 arms). Primary endpoints: Efficacy of quetiapine for the treatment of psychosis and/or agitation at 10 weeks and Safety and tolerability of quetiapine at 10 weeks. Started Jul 2002; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Quetiapine

    Atypical antipsychotic (QUET)

  • Placebo

    Matching placebo

03

Who it enrols

Patients with probable Alzheimer's disease, dementia with Lewy bodies, or Parkinson's disease with dementia, experiencing psychosis and/or agitation, with coexisting extrapyramidal motor features.

04

Endpoints

Primary

  • Efficacy of quetiapine for the treatment of psychosis and/or agitation

  • Safety and tolerability of quetiapine

Secondary

  • Influence on parkinsonism (motor function)

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