b72324f2e53b4c69…

Study
ID: NCT000092171,288 bytesFirst seen Jun 12, 20261 collection

Fields

NameValue
briefSummaryThe optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it. In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo. The primary outcome is the time to relapse of psychosis or behavioral disturbance.
completionDate2004-12
conditions["Alzheimer's Disease","Psychosis","Agitation"]
enrollmentCount44
enrollmentTypeACTUAL
nctIdNCT00009217
phasePHASE4
sponsorIdnew-york-state-psychiatric-institute
startDate1999-01
statusCOMPLETED
studyTypeINTERVENTIONAL
titleTreatment of Behavioral Symptoms in Alzheimer's Disease
urlhttps://clinicaltrials.gov/study/NCT00009217

Canonical JSON

{
  "id": "NCT00009217",
  "type": "Study",
  "data": {
    "briefSummary": "The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear.\n\nThe objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it.\n\nIn Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo.\n\nThe primary outcome is the time to relapse of psychosis or behavioral disturbance.",
    "completionDate": "2004-12",
    "conditions": [
      "Alzheimer's Disease",
      "Psychosis",
      "Agitation"
    ],
    "enrollmentCount": 44,
    "enrollmentType": "ACTUAL",
    "nctId": "NCT00009217",
    "phase": "PHASE4",
    "sponsorId": "new-york-state-psychiatric-institute",
    "startDate": "1999-01",
    "status": "COMPLETED",
    "studyType": "INTERVENTIONAL",
    "title": "Treatment of Behavioral Symptoms in Alzheimer's Disease",
    "url": "https://clinicaltrials.gov/study/NCT00009217"
  }
}

Appears in 1 collection

nih/clinical-trials1 version · Jun 12, 2026

Full hash:b72324f2e53b4c691a37c864a3b234b9955f81e4a084aa51cbce8614bf85e810