Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-19 @ 11:46 AM
Study NCT ID:
NCT02260167
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2014-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2014-10-05', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': '6 months', 'description': 'Looking to see what percent of patients show improvement'}], 'secondaryOutcomes': [{'measure': 'Mini Mental Status Exam (MMSE)', 'timeFrame': '6 months'}, {'measure': "Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)", 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'Dementia']}, 'descriptionModule': {'briefSummary': 'Treating with measures that may improve metabolic functioning of neurons in an integrated protocol', 'detailedDescription': 'Most organ failure results in modest drops in function until over 50% of function is lost. At a certain point, even modest drops in physiologic activity result in dramatic drops in clinical function. Though less homogeneous than in other organs, clinical experience and the literature suggests a similar process occurs in the brain. The hypothesis is that by using an integrated protocol to, essentially, "tune up" neuronal function, a 5-10 % improvement in metabolic functioning may translate to significant improvement in clinical functioning. This tune-up will include "MIND":\n\nM- Metabolism-- optimizing hormonal function I- Infections-- looking for and eliminating N- Nutritional and herbal support D- Drugs- Weaning subjects off unneeded medications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A diagnosis of Alzheimer's and/or dementia with an MMSE score over 12 or being ambulatory and able to travel outside the home with assistance.\n* Must have a caregiver living with them.\n\nExclusion Criteria:\n\n* Overt progressive and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness.\n* Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months"}, 'identificationModule': {'nctId': 'NCT02260167', 'acronym': 'MIND', 'briefTitle': "Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol", 'organization': {'class': 'OTHER', 'fullName': 'Practitioners Alliance Network'}, 'officialTitle': "Effective Treatment of Alzheimer's and Dementia With the MIND Protocol", 'orgStudyIdInfo': {'id': 'PAN-ALZ002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with MIND', 'interventionNames': ['Other: A mix of natural treatments and medications']}], 'interventions': [{'name': 'A mix of natural treatments and medications', 'type': 'OTHER', 'otherNames': ['MIND Protocol'], 'armGroupLabels': ['Treatment with MIND']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96740', 'city': 'Kailua', 'state': 'Hawaii', 'country': 'United States', 'facility': 'PAN', 'geoPoint': {'lat': 21.40241, 'lon': -157.74054}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Practitioners Alliance Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}