{
  "id": "ctis:2023-505430-10-00",
  "euct": "2023-505430-10-00",
  "title": "TAP-TAU",
  "publicTitle": "TAP-TAU",
  "fullTitle": "The clinical value of tau PET in the memory clinic (TAP-TAU)",
  "shortTitle": null,
  "status": "Authorised",
  "statusCode": "4",
  "startDateEU": "2024-10-10",
  "decisionDate": "2023-12-21T10:38:44.655",
  "publishDate": "2026-03-19T02:32:08.844353511",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Mild cognitive impairment and dementia",
      "rareDisease": false
    }
  ],
  "therapeuticAreas": [
    {
      "code": "10",
      "name": "Diseases [C] - Nervous System Diseases [C10]"
    }
  ],
  "trialCategory": {
    "phaseCode": "10",
    "categoryCode": "2",
    "lowIntervention": false
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2023-12-01",
    "estimatedEndDate": "2026-12-01",
    "estimatedGlobalEndDate": null
  },
  "countries": [
    {
      "name": "Netherlands",
      "publicStatusCode": "4",
      "firstDecisionDate": "2023-12-21T10:38:44.655",
      "lastDecisionDate": "2026-03-18T10:39:37.263",
      "history": [
        {
          "source": "application_country_status",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2023-12-21",
          "date": "2023-12-21",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_country_status",
          "applicationBusinessKey": "SM-2",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-04-08",
          "date": "2023-12-21",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_country_status",
          "applicationBusinessKey": "SM-4",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2026-03-18",
          "date": "2023-12-21",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "date": "2023-12-21T10:38:44.655",
          "isRMS": true
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "SM-1",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": null,
          "eventType": "decision",
          "date": "2024-09-06T15:40:06.292",
          "isRMS": true
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "SM-2",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "date": "2025-04-08T16:00:10.524",
          "isRMS": true
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "SM-4",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "date": "2026-03-18T10:39:37.263",
          "isRMS": true
        }
      ]
    }
  ],
  "applications": [
    {
      "id": "application:2023-505430-10-00:in",
      "businessKey": "IN",
      "type": "INITIAL",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2023-09-12",
      "decisionDate": "2023-12-21",
      "decisions": [
        {
          "mscName": "Netherlands",
          "decisionDate": "2023-12-21T10:38:44.655",
          "decision": "authorized_conditions",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "INITIAL",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "Netherlands",
          "mscName": "Netherlands",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "decisionDate": "2023-12-21",
          "firstDecisionDate": "2023-12-21",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2023-12-21",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    },
    {
      "id": "application:2023-505430-10-00:sm-1",
      "businessKey": "SM-1",
      "type": "SUBSTANTIAL MODIFICATION",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2024-07-08",
      "decisionDate": "2024-09-06",
      "decisions": [
        {
          "mscName": "Netherlands",
          "decisionDate": "2024-09-06T15:40:06.292",
          "decision": "authorized",
          "assessmentOutcome": null,
          "eventType": "decision",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "isRMS": true
        }
      ],
      "countryStatuses": []
    },
    {
      "id": "application:2023-505430-10-00:sm-2",
      "businessKey": "SM-2",
      "type": "SUBSTANTIAL MODIFICATION",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2025-01-29",
      "decisionDate": "2025-04-08",
      "decisions": [
        {
          "mscName": "Netherlands",
          "decisionDate": "2025-04-08T16:00:10.524",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "Netherlands",
          "mscName": "Netherlands",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "decisionDate": "2023-12-21",
          "firstDecisionDate": "2023-12-21",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-04-08",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    },
    {
      "id": "application:2023-505430-10-00:sm-4",
      "businessKey": "SM-4",
      "type": "SUBSTANTIAL MODIFICATION",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2026-03-06",
      "decisionDate": "2026-03-18",
      "decisions": [
        {
          "mscName": "Netherlands",
          "decisionDate": "2026-03-18T10:39:37.263",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "Netherlands",
          "mscName": "Netherlands",
          "trialStatus": "Authorised",
          "decision": "authorized_conditions",
          "decisionDate": "2023-12-21",
          "firstDecisionDate": "2023-12-21",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2026-03-18",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:43f8a8127de3964fa5bb2578",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[0].endPoint",
      "term": "artificial intelligence",
      "snippet": "Performance of tau PET compared to novel blood-based biomarkers and artificial intelligence (AI) based classifiers."
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2023-505430-10-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2023-505430-10-00?lang=en"
  },
  "slug": "2023-505430-10-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "a0f73bd5933023c914b9650bcacec9fb23dc8cfb353c45a11dc5cc0ab4616921"
}