ClinicalTrials.gov Study Detail Lookup by NCT ID

{
  "nct_id": "NCT03232697"
}

{
  "url": "https://clinicaltrials.gov/study/NCT03232697",
  "title": {
    "brief": "French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)",
    "official": "French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)"
  },
  "design": {
    "phases": [
      "NA"
    ],
    "enrollment": 236,
    "study_type": "INTERVENTIONAL",
    "enrollment_type": "ACTUAL"
  },
  "nct_id": "NCT03232697",
  "source": "ClinicalTrials.gov",
  "status": {
    "overall": "COMPLETED",
    "start_date": "2017-07-12",
    "completion_date": "2019-08-08",
    "verification_date": "2020-08",
    "primary_completion_date": "2019-08-08"
  },
  "sponsor": {
    "lead": "University Hospital, Lille",
    "lead_class": "OTHER",
    "collaborators": []
  },
  "success": true,
  "keywords": [],
  "locations": [
    {
      "city": "Lille",
      "country": "France",
      "facility": "University Hospital"
    }
  ],
  "conditions": [
    "Cognitive Symptom",
    "Evaluations, Diagnostic Self"
  ],
  "eligibility": {
    "sex": "ALL",
    "max_age": "89 Years",
    "min_age": "40 Years",
    "criteria": "Inclusion Criteria:\n\nHealthy Volunteers\n\n* Volunteers, BMI \\<26\n* free from neurological, psychiatric, metabolic or cardiac pathologies;\n* Absence of active metabolic or cardiac diseases, unstabilized under treatment\n* Pregnant test negative\n\nPatients\n\n* Patients suffering from pathologies that may be accompanied by cognitive decline or dementia (Alzheimer's disease, Parkinson's and Huntington's disease, diabetes) that meet the usual diagnostic criteria for these diseases;\n* Patients should not start treatment of a new therapeutic class under test\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Illiterate subjects\n* Presence of uncorrected visual or auditory disturbances\n* \"Alcohol use disorder\" observed at the Mini International Neuropsychiatric Inventory (MINI);\n* \"Substance use disorder\" observed at the MINI;\n* Participation in a therapeutic trial or in an exclusion period from a previous clinical trial;\n* Patient whose physical or mental condition does not allow them to pass the study tests;\n* Persons under guardianship or under trusteeship;\n* Recent cognitive assessment (less than 6 months) by the classic MoCA",
    "std_ages": [
      "ADULT",
      "OLDER_ADULT"
    ],
    "healthy_volunteers": true
  },
  "brief_summary": "The aim of the study is to validate a french version of the 5 minutes version of the Montreal Cognitive Assessment as compared to the french full version of this test.",
  "results_summary": null,
  "primary_outcomes": [
    {
      "measure": "Correlation between scores obtained with the different versions of the MOCA",
      "time_frame": "30 to 40 days",
      "description": "To measure the correlation between the results obtained at the short and full versions of the MOCA"
    }
  ],
  "secondary_outcomes": [
    {
      "measure": "Performance of the short version of the MOCA",
      "time_frame": "30 to 40 days",
      "description": "Receiver operator characteristic (ROC) analyses of the short version of MOCA to determine cognitive impairment as compared to full version as a gold-standard"
    },
    {
      "measure": "Test-retest reliability",
      "time_frame": "30 to 40 days",
      "description": "To determine the test-retest reliability of the short version of the MOCA"
    },
    {
      "measure": "Inter-rater reliability",
      "time_frame": "30 to 40 days",
      "description": "To determine the inter-rater reliability of the short version of the MOCA"
    }
  ],
  "detailed_description": "The Montreal Cognitive Assessment (MOCA) is a test used to detect cognitive impairments. This test is available in different languages including french. A short version (the 5 minutes MOCA) has also been validated through a phone call use that allows to develop some epidemiological approaches. Nevertheless, this short version has not been validated in french.\n\nThe main aim of the study is to validate the french translation of the short version of the MOCA as compared the the full french version of the test.\n\nTo validate the short version, several groups of subjects will be included : healthy subjects, Alzheimer disease patients, Parkinson or Huntington diseases patients as well as diabetic patients.\n\nThe inclusion of both healthy subjects and patients with different types of cognitive impairments will allow to validate the short version of the test.\n\nAll subjects and patients will first be submitted to the full version of the MOCA during a face to face procedure. Thirty to forty days later, they will be submitted to the short version of the test through a phone call performed by an independent rater.\n\nSubgroups of healthy subjects and patients will also be used to determine the test-retest and inter-rater reliability of the short version of the MOCA."
}

{
  "example": {
    "title": {
      "brief": "SUSTAIN 6 — Semaglutide and Cardiovascular Outcomes"
    },
    "nct_id": "NCT03232697",
    "success": true,
    "eligibility": {
      "sex": "ALL",
      "min_age": "18 Years"
    },
    "primary_outcomes": [
      {
        "measure": "Time to first MACE event",
        "time_frame": "104 weeks"
      }
    ]
  }
}