Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-04-06 @ 9:50 AM
Study NCT ID:
NCT02991235
Status:
UNKNOWN
Last Update Posted:
2018-01-19
First Post:
2016-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).', 'timeFrame': 'Comparison of the R-BANS score, from baseline to 6 months.'}, {'measure': 'Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).', 'timeFrame': 'Comparison of the WMS score, from baseline to 6 months.'}, {'measure': 'Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).', 'timeFrame': 'Comparison of the total memory composite score, from baseline to 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.', 'detailedDescription': "Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged from 60 to 85 years.\n* Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA.\n* Patients with mild Alzheimer's disease according to MMSE.\n* Patients with ability to ingest oral medication.\n* Patients able to undergo a MRI.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women or planning a pregnancy during the study.\n* Patients and caregivers unwilling or unable to perform cognitive testing.\n* Patients taking part in an interventional clinical trial.\n* Patients who have a risk of non-compliance to the study procedures.\n* Patients with clinical or significant laboratory abnormalities.\n* Patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria."}, 'identificationModule': {'nctId': 'NCT02991235', 'briefTitle': "Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioiberica'}, 'officialTitle': "Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study", 'orgStudyIdInfo': {'id': 'BIO-PRJ-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRJ212', 'description': 'PRJ212 is a nutritional product with active food ingredients.', 'interventionNames': ['Dietary Supplement: PRJ212']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is like PRJ212 without active food ingredients.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'PRJ212', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 capsules of study product will be taken daily and orally.', 'armGroupLabels': ['PRJ212']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 capsules of study product will be taken daily and orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Fundació ACE', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Martinez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bioiberica, S.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioiberica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}