Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:54 AM
Study NCT ID:
NCT07443566
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10-Year Survival After Acute Hip Fracture in Patients With Preclinical/Clinical Alzheimer Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality / survival at 10 years after index hip fracture surgery', 'timeFrame': 'up to 10 years post-surgery'}], 'secondaryOutcomes': [{'measure': 'Time to death from date of surgery (survival time)', 'timeFrame': '10 years ( up to 10 years post-surgery)', 'description': 'All-cause mortality /survival at 10 years after index hip fracture surgery'}, {'measure': 'Association between baseline CDR category and long-term mortality', 'timeFrame': 'up to 10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures (ICD-10 72.01-72.2)', 'Alzheimer s Disease', 'Dementia']}, 'descriptionModule': {'briefSummary': "This study is a 10-year follow-up of a previously enrolled cohort of patients who underwent surgery for acute hip fracture with spinal anesthesia and had pre-fracture cognitive status assessed (Clinical Dementia Rating, CDR) and cerebrospinal fluid (CSF) biomarkers related to Alzheimer's disease measured (e.g., Aβ42/Aβ40 ratio, total tau, phosphorylated tau). The primary aim is to determine long-term survival at 10 years after index hip fracture surgery and to evaluate whether baseline cognitive status and/or Alzheimer-type CSF biomarker profiles are associated with long-term mortality.", 'detailedDescription': 'Participants were originally included during admission for acute hip fracture (October 2013-June 2015) at Sahlgrenska University Hospital, Mölndal, Sweden, and underwent lumbar CSF sampling at spinal anesthesia induction. Cognitive status prior to the fracture was assessed using CDR. Mortality will be ascertained through Swedish national registries. The follow-up extends survival assessment to approximately 10 years after surgery. Analyses will compare survival across baseline cognitive status categories and biomarker-defined groups (e.g., normal vs abnormal Aβ42/Aβ40 ratio), and may adjust for baseline covariates (e.g., age, sex, ASA class / hip fracture risk scores if available from original dataset).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Older adults (≥65 years) who were admitted for acute hip fracture and underwent surgical repair under spinal anesthesia at Sahlgrenska University Hospital, Mölndal, Sweden. Participants were originally enrolled between October 2013 and June 2015 and had pre-fracture cognitive status assessed using the Clinical Dementia Rating scale and cerebrospinal fluid biomarkers related to Alzheimer's disease collected at baseline. The present study is a long-term follow-up of this cohort.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant enrolled in the original acute hip fracture cohort (index surgery during Oct 2013-Jun 2015 at Sahlgrenska University Hospital, Mölndal)\n* Available personal identity number enabling linkage to Swedish registries\n* Baseline cognitive assessment (CDR) and/or CSF biomarker data available from the index admission\n\nExclusion Criteria:\n\nMissing linkage information preventing ascertainment of vital status\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07443566', 'briefTitle': '10-Year Survival After Acute Hip Fracture in Patients With Preclinical/Clinical Alzheimer Pathology', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': "10-Year Follow-up of Mortality in Patients With Acute Hip Fractures: Associations With Pre-Alzheimer's/Alzheimer's Disease and Cerebrospinal Fluid Biomarkers", 'orgStudyIdInfo': {'id': 'HOFTDEM_10 years'}}, 'contactsLocationsModule': {'locations': [{'zip': '431 80', 'city': 'Mölndal', 'state': 'Västra Götaland County', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospit', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bengt Nellgård', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bengt Nellgård', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}