Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01313806
Status:
WITHDRAWN
Last Update Posted:
2011-05-30
First Post:
2011-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Magnetic Fields to Treat Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-27', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)", 'timeFrame': 'end of treatment at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale', 'timeFrame': 'end of treatment at 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dementia', 'memory loss', 'cognitive decline'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.", 'detailedDescription': 'The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator may improve cognitive functioning and memory in individuals with a diagnosis of Alzheimer"s dementia, as an adjunctive therapy to standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be considered eligible for participation in this clinical study, a subject must satisfy each of the following "Inclusive Conditions" criteria.\n\n* Current diagnosis of Alzheimer\'s Disease appropriately documented by the patients physician and/or neurologist\n* Documentation verifying that other generally recognized causes of dementia have been ruled out by prior physician evaluations\n* Mild to Moderate Dementia, as evidenced by a score of not less than 12 nor greater than 26 on the Mini Mental Status Exam (MMSE).\n* Subject is ambulatory\n* A Study Partner who can attend all study visits with the subject. Study Partner being defined as an adult who has at least 10 hours/week of contact with the subject, and can accompany the subject to all testing and treatment study visits.\n* Stable "anti-dementia" medication regimen without significant side effects for at least 3 months, and on stable medication (unrelated to anti-dementia) without significant side effects for at least 1 month; willingness and ability to maintain the stable medication regimen throughout the course of the study.\n* Willingness and ability to present to the testing center for all study evaluations\n* Willingness and ability to present to the treatment center for all study treatments (exposure to the Resonator™)\n* Willingness to maintain stable diet and activity regimen for the duration of the study.\n* Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve cognition and mental functioning\n* Willing and able to abstain from any medications that could affect cognition and mental functioning during the course of the study\n* Male or female.\n* Any ethnic background.\n* Age 55 and older.\n\nExclusion Criteria A subject will be considered ineligible for participation in this clinical study if he or she satisfies any one or more of the following exclusive conditions criteria.\n\n* Change in anti-dementia medical regimen within 3 months prior to initiation of study.\n* Confirmed diagnosis other non-Alzheimer\'s type of dementia\n* Significant neurologic or psychiatric illness other than Alzheimer\'s disease\n* Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.\n* Previous surgical interventions involving prosthetics or implants comprised of ferrous metals, or pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.\n* Reported consumption of more than 14 alcoholic drinks per week.\n* Uncontrolled hypertension.\n* Uncontrolled atrial fibrillation or other uncontrolled arrhythmias, e.g. tachycardia, bradycardia.\n* Uncontrolled seizure disorder.\n* History of seizures or usage of anti-seizure medications that, in the opinion of the investigator, participation in this trial would represent a risk to the subject.\n* Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject\'s health or ability to complete the entire study, in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT01313806', 'briefTitle': "Study of Magnetic Fields to Treat Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'pico-tesla Magnetic Therapies, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer"s Disease in Addition to Standard of Care', 'orgStudyIdInfo': {'id': 'WIRB 1123661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resonator', 'description': 'Treatment with active Resonator device using low level magnetic fields', 'interventionNames': ['Device: Resonator']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Resonator', 'type': 'DEVICE', 'description': 'Treatment group vs. Placebo group', 'armGroupLabels': ['Resonator']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'Inactive Resonator Device', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mile High Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}], 'overallOfficials': [{'name': 'Jack A Klapper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mile High Research Center'}, {'name': 'Miguel Trevino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innovative Research of West Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'pico-tesla Magnetic Therapies, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC', 'oldOrganization': 'Pico-Tesla Magnetic Therapies, LLC'}}}}