Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-30 @ 10:03 PM
Study NCT ID:
NCT00357357
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2006-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-20', 'studyFirstSubmitDate': '2006-07-26', 'studyFirstSubmitQcDate': '2006-07-26', 'lastUpdatePostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients", 'timeFrame': 'June 2008'}], 'secondaryOutcomes': [{'measure': "Validate biochemical markers relevant to Alzheimer's disease", 'timeFrame': 'June 2008'}, {'measure': 'Assess the suitability of chosen HF0220 dose levels for future studies', 'timeFrame': 'June 2008'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Alzheimer's disease"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '12859344', 'type': 'BACKGROUND', 'citation': 'Pringle AK, Schmidt W, Deans JK, Wulfert E, Reymann KG, Sundstrom LE. 7-Hydroxylated epiandrosterone (7-OH-EPIA) reduces ischaemia-induced neuronal damage both in vivo and in vitro. Eur J Neurosci. 2003 Jul;18(1):117-24. doi: 10.1046/j.1460-9568.2003.02734.x.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES\n\nINCLUSION CRITERIA:\n\nParticipants must meet the following inclusion criteria to be eligible.\n\n* Male or Female (age over 55 years). Females must be non-child-bearing potential. Male patients with female partners of child-bearing potential should use effective contraception for the duration of the Study.\n* A diagnosis of probable Alzheimer's disease established in accordance with the National Institute of Neurological and Communicative Disorders and Stroke /Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) classification.\n* Severity of dementia of mild to moderate as assessed by the Mini-Mental State Examination (MMSE) score of 12-24.\n* Patients must be living in the community living with or have at least daily visits from a responsible carer. The carer should be capable of assisting with the patient's medication, and prepared to attend with the patient for assessment.\n* Written consent should be obtained from the patient and responsible carer.\n\nEXCLUSION CRITERIA\n\nPatients will not be eligible to participate in the study if they meet any of the following criteria:\n\n* Primary, secondary or pseudodementias other than probable Alzheimer's disease.\n* Clinically significant and/or uncontrolled condition or other significant medical disease.\n* If taking medication for symptoms of dementia, the patient must be stable on therapy and have been taking these for a minimum of 3 months prior to enrolment.\n* Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity.\n* Non-steroidal or steroidal anti-inflammatory agents. However, patients stable on low dose aspirin (upto 300mg/day) for at least 3 month prior to enrolment will be eligible.\n* Taking anti-oxidant supplements.\n* Active smokers of tobacco.\n* Considered to be malnourished (body mass index \\<19).\n* Patients in whom a lumbar puncture is contra-indicated."}, 'identificationModule': {'nctId': 'NCT00357357', 'briefTitle': "European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hunter-Fleming Ltd'}, 'officialTitle': "Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease", 'orgStudyIdInfo': {'id': 'HF0220/003'}, 'secondaryIdInfos': [{'id': '2005-005791-32'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group1', 'description': '4x 7 day rising dose', 'interventionNames': ['Drug: HF0220']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group2', 'description': '4x, 7 day rising dose', 'interventionNames': ['Drug: HF0220']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group3', 'description': '28 day fixed lower dose', 'interventionNames': ['Drug: HF0220']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group4', 'description': '28 day fixed upper dose', 'interventionNames': ['Drug: HF0220']}], 'interventions': [{'name': 'HF0220', 'type': 'DRUG', 'description': 'comparison of different dosages of drug', 'armGroupLabels': ['Group1', 'Group2', 'Group3', 'Group4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Visakhapatnam', 'state': 'ANDH PRAD', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'city': 'Bangalore', 'state': 'Karna', 'country': 'India', 'facility': 'Manipal Hospital,', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Thiruvananthapuram', 'state': 'Kerala', 'country': 'India', 'facility': 'Sree Chitra Tirunal Institute for Medical Sciences and Technology', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'city': 'Hyderabaad', 'state': 'Panjagutta', 'country': 'India', 'facility': "Nizam's Institute of Medical Sciences,"}, {'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Madras Medical College & Government General Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': 'S205D2', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Malmo University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': 'SE14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinksa Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'BA2 5RP', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Research Institute for Care of the Elderly', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'SO30 3JB', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Memory Assessment and Research Centre', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SN1 4HZ', 'city': 'Swindon', 'country': 'United Kingdom', 'facility': 'Kingshill Research Centre', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}], 'overallOfficials': [{'name': 'David Wilkinson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Principal Investigator'}, {'name': 'Niels Andreasen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Co-Ordinating Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter-Fleming Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr John Fox ,Chief Operations Officer', 'oldOrganization': 'Hunter-Fleming Ltd'}}}}