Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT03883633
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2019-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reversal of Cognitive Decline (ReCODE) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in short-time memory function', 'timeFrame': 'Given at enrollment and repeated at three months, six months and nine months after enrollment', 'description': 'Participants will be given an on-line assessment to test memory and recall using CNS (Central Nervous System) Vitals assessment.'}, {'measure': 'Changes in cognitive function', 'timeFrame': 'Given at enrollment and repeated at three months, six months and nine months after enrollment', 'description': 'Participants will be evaluated for cognitive capability using the Montreal Cognitive Assessment (MoCA)'}, {'measure': 'Perceived changes in capability assessed by input from care giver or family member', 'timeFrame': 'Given at enrollment and repeated at three months, six months and nine months after enrollment', 'description': "Care givers will be surveyed about the participants capability using an assessment based on the Alzheimer's Questionnaire 21-question assessment (AQ-21)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's Disease", 'Cognitive Decline', 'MCI'], 'conditions': ['Alzheimer Disease', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Prospective study on patients enrolled in the ReCODE treatment protocol', 'detailedDescription': "The objective of the study is to determine if the ReCODE treatment has a measurable impact on the typical progression of neurocognitive decline observed in patients with Alzheimer's Disease (AD) and patients who are exhibiting Mild Cognitive Impairment (MCI). MCI is often a precursor to an AD diagnosis. For this study, there will be no distinction made between participants who have been diagnosed with AD and those who show signs of MCI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People who have signs of reduced neurocognitive function', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 45 to 76 years old\n* Adults of any gender, race or ethnicity\n* Subjects must have cognitive impairment as demonstrated by a combination of AQ-21 over 5 and either a MOCA 26 or below or a CNS Vitals screening assessment in the MCI in the bottom 70th percentile or 2 of the subtests in the bottom 50th percentile.\n* Proficient in spoken and written English for consenting as well as for study participation.\n* Must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.\n* Regular access to a computer and an internet connection since certain aspects of the program (e.g. cognitive training) are delivered electronically\n* Willing and able to follow the protocol if the treating physician determines that is required for appropriate patient care.\n\nExclusion Criteria:\n\n* Uncontrolled major medical illness, seizures, cardiovascular or cerebrovascular instability.\n* A major psychiatric diagnosis that affects activities of daily living (ADL) or functioning.\n* Currently taking psychoactive medications known to impact cognition.\n* Use of statin therapy, unless eligible to discontinue.\n* Use of anticoagulation therapy or history of deep vein thrombosis.\n* MRI findings of hydrocephalus, focal stroke, extensive white matter disease or brain tumor.\n* Experienced Traumatic Brain Injury (TBI) that is severe enough that it has an ongoing impact on patient function on a regular basis.\n* Lack of support (either family member or caregiver) to assist with following the treatment protocol.\n* Active cancer, cancer within the past five years or any history of breast cancer.\n* Inability to exercise.\n* Inability to use a computer, or no computer access.\n* Unwillingness or ineligibility to use bioidentical hormone replacement.\n* Pregnancy or any chance of becoming pregnant during the course of the study period.\n* Presence of an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Disease, Frontotemporal Disease, Chronic Traumatic Encephalopathy, Korsakoff's Syndrome).\n* Diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.\n* Previous treatment or experience with ReCODE."}, 'identificationModule': {'nctId': 'NCT03883633', 'acronym': 'RECODE', 'briefTitle': 'Reversal of Cognitive Decline (ReCODE) Study', 'organization': {'class': 'OTHER', 'fullName': 'QuesGen Systems Inc'}, 'officialTitle': 'Reversal of Cognitive Decline (ReCODE) Study', 'orgStudyIdInfo': {'id': 'RECODE-1018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrolled Participants', 'description': 'All participants enrolled will be tracked from initial assessment to study completion.', 'interventionNames': ['Behavioral: ReCODE Protocol']}], 'interventions': [{'name': 'ReCODE Protocol', 'type': 'BEHAVIORAL', 'otherNames': ['Bredesen Protocol'], 'description': "Functional medicine approach to address symptoms of Alzheimer's and cognitive decline", 'armGroupLabels': ['Enrolled Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94903', 'city': 'San Rafael', 'state': 'California', 'country': 'United States', 'facility': 'Ann Hathaway MD', 'geoPoint': {'lat': 37.97353, 'lon': -122.53109}}, {'zip': '94597', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Wellness', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '97520', 'city': 'Ashland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Memory Center', 'geoPoint': {'lat': 42.19458, 'lon': -122.70948}}], 'overallOfficials': [{'name': 'Ann Hathaway, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ann Hathaway MD'}, {'name': 'Deborah Gordon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Memory Center'}, {'name': 'Kat Toups, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kat Toups MD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QuesGen Systems Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}