Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT02593318
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Oxaloacetate in Alzheimer's Disease (TOAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062907', 'term': 'Oxaloacetic Acid'}], 'ancestors': [{'id': 'D010071', 'term': 'Oxaloacetates'}, {'id': 'D010070', 'term': 'Oxalates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007651', 'term': 'Keto Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rswerdlow@kumc.edu', 'phone': '9135885000', 'title': 'Russell H. Swerdlow, MD', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day', 'description': 'Participants take 1 gram of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 2 - Oxaloacetate (OAA)2 Gram/Day', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Dose Limiting Toxicity Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day', 'description': 'Participants take 1 gram of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study'}, {'id': 'OG001', 'title': 'Part 2 - Oxaloacetate (OAA)2 Gram/Day', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Change from Baseline to Week 4', 'description': 'The number of dose limiting toxicity events will be determined by change in safety labs, physical and neurological exams, vital signs, cognitive measures, signs and symptoms.', 'unitOfMeasure': 'Dose Limiting Toxicity Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brain Glucose Metabolic Rate as Determined by Fluorodeoxyglucose Positron Emission Tomography (FDG PET)', 'timeFrame': 'Change from Baseline to Week 4', 'description': 'Fluorodeoxyglucose positron emission tomography (FDG PET)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Brain Lactate Levels as Determined by Magnetic Resonance Spectroscopy (MRS)', 'timeFrame': 'Change from Baseline to Week 4', 'description': 'magnetic resonance spectroscopy (MRS)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Plasma Levels in 500 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day - Baseline', 'description': 'Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Baseline blood sample obtained prior to 500 mg OOA administered'}, {'id': 'OG001', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 60 Minutes Post Administration of Dose', 'description': 'Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Baseline blood sample drawn 60 minutes post administration of dose.'}, {'id': 'OG002', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day - 90 Minutes Post Administration of Dose', 'description': 'Oxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn 90 minutes post administration of dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '102', 'groupId': 'OG000'}, {'value': '63', 'spread': '55', 'groupId': 'OG001'}, {'value': '87', 'spread': '80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from dose to 60 min post dose and 90 min post dose', 'description': 'For the 1 g/ day (500 mg bid) cohort, baseline blood sample will be obtained just before 500 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose. The amount of OOA in the blood will be measured at each of the three time points.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Levels in 1000 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaloacetate (OAA) 2 Gram/Day - Baseline Blood Sample', 'description': 'Participants take 2 gram of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn at baseline prior to dose administration.'}, {'id': 'OG001', 'title': 'Oxaloacetate (OAA)2 Gram/Day - 60 Minutes Post Administration', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample drawn at 60 minutes post administration of dose.'}, {'id': 'OG002', 'title': 'Oxaloacetate (OAA)2 Gram/Day - 90 Minutes Post Administration of Dose', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study. Blood sample to be drawn 90 minutes post administration of dose'}], 'classes': [{'categories': [{'measurements': [{'value': '1400', 'spread': '962', 'groupId': 'OG000'}, {'value': '1355', 'spread': '690', 'groupId': 'OG001'}, {'value': '1363', 'spread': '759', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from dose to 60 min post dose and 90 min post dose', 'description': 'For the 2 g/ day (1000 mg bid) cohort, baseline blood sample will be obtained before 1000 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose. Plasma levels of OOA will be measured at each of the three timepoints.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day', 'description': 'Participants take 1 gram of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study'}, {'id': 'FG001', 'title': 'Part 2 - Oxaloacetate (OAA)2 Gram/Day', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Original plan was to enroll 30 participants. After enrolling 30 participants, two enrolled participants were withdrawn from the study after assignment to groups but did not complete post treatment data collection. Therefore those two were replaced so that total number of participants who completed post treatment data was 30, increasing the total number of enrolled participants to 32.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 - Oxaloacetate (OAA) 1 Gram/Day', 'description': 'Participants take 1 gram of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study'}, {'id': 'BG001', 'title': 'Part 2 - Oxaloacetate (OAA)2 Gram/Day', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks\n\nOxaloacetate (OAA): Pills to be taken orally in 500mg or 1000mg doses two times per day depending on the part of the study'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '71.3', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '70.7', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline MMSE', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '21.9', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '21.7', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Mini-Mental State Exam (MMSE) is a 30 point questionnaire that measures cognitive impairment. Score ranges from 0 to 30 and are adjusted based on education level of the participant. A score of 20 to 24 suggests mild dementia, a score of 13 to 20 suggest moderate dementia, and a score of 12 or less suggests severe dementia.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-08-31', 'size': 515770, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-17T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2015-10-08', 'resultsFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-17', 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Dose Limiting Toxicity Events', 'timeFrame': 'Change from Baseline to Week 4', 'description': 'The number of dose limiting toxicity events will be determined by change in safety labs, physical and neurological exams, vital signs, cognitive measures, signs and symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Brain Glucose Metabolic Rate as Determined by Fluorodeoxyglucose Positron Emission Tomography (FDG PET)', 'timeFrame': 'Change from Baseline to Week 4', 'description': 'Fluorodeoxyglucose positron emission tomography (FDG PET)'}, {'measure': 'Change in Brain Lactate Levels as Determined by Magnetic Resonance Spectroscopy (MRS)', 'timeFrame': 'Change from Baseline to Week 4', 'description': 'magnetic resonance spectroscopy (MRS)'}, {'measure': 'Plasma Levels in 500 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose', 'timeFrame': 'Change from dose to 60 min post dose and 90 min post dose', 'description': 'For the 1 g/ day (500 mg bid) cohort, baseline blood sample will be obtained just before 500 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose. The amount of OOA in the blood will be measured at each of the three time points.'}, {'measure': 'Plasma Levels in 1000 mg Bid Cohort at Baseline, 60 and 90 Minutes Post-Dose', 'timeFrame': 'Change from dose to 60 min post dose and 90 min post dose', 'description': 'For the 2 g/ day (1000 mg bid) cohort, baseline blood sample will be obtained before 1000 mg OAA is administered. Blood samples to be drawn again at 60 min and 90 min post administration of dose. Plasma levels of OOA will be measured at each of the three timepoints.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['energy metabolism', 'oxaloacetate'], 'conditions': ["Alzheimer's Disease (AD)"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at doses of up to 2 grams per day in people with Alzheimer's disease (AD).", 'detailedDescription': "Alzheimer's disease (AD) is a progressive brain disorder that causes memory and thinking problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of your cells that produce energy) might be linked to symptoms of AD. Some studies have shown that the brains in patients with Alzheimer's disease have reduced mitochondrial activity, have fewer mitochondria present in the nerve cells, and have reduced ability to utilize glucose (sugar) for energy.\n\nOxaloacetate (OAA) is a natural chemical that has been shown to have an effect on brain mitochondrial activity and brain energy in non-human animals.\n\nThis study is divided into two parts. In the first part of the study, researchers will test whether a dose of 1 gram per day of OAA, taken for approximately 4 weeks in 15 people with AD is safe and tolerable. After all 15 participants in part 1 have completed their participation, and it is determined that the study drug was safe at this dose, the second part of the study will begin. In part 2, researchers will test a dose of 2 grams per day of OAA, taken for approximately 4 weeks in 15 people with AD, to assess safety at this dose.\n\nParticipants will be in this study for about 10 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of probable Alzheimer's disease (AD) per McKhann et al. criteria \\[9\\];\n* Have a clinical dementia rating (CDR) score of 0.5 or 1 at time of their last University of Kansas Alzheimer's Disease Center (KU ADC) assessment;\n* Have a Mini Mental Status Exam (MMSE) score of 15-28 at the TOAD screening visit;\n* Have a reliable and competent study partner who is willing to accompany the participant to all study visits, monitor compliance of study medication administration, and observe/report any changes in the participant's health throughout the study duration;\n* Are on stable doses of concurrent medications for at least 4 weeks prior to the TOAD screening visit; and\n* Speaks English as his/her primary language.\n* If female of child-bearing potential, must have a negative urine pregnancy test at TOAD screening visit (and must agree to use of contraception throughout the trial)\n\nExclusion Criteria:\n\n* Dementia due to causes other than AD;\n* Potentially confounding, serious, or unstable medical conditions such as:\n\n * insulin-dependent diabetes mellitus\n * cancer within the past 3 years (except basal cell, squamous cell, or localized prostate cancer)\n * a recent cardiac event (i.e. heart attack, angioplasty, etc. within the 6 months prior to screening visit)\n * other conditions that pose a potential safety risk or confounding factor in the investigator's opinion;\n* Any abnormal physical examination assessment or vital sign assessment at TOAD screening visit that is deemed to be clinically significant by the principal investigator;\n* Any abnormal clinical laboratory test result at TOAD screening visit that is deemed to be clinically significant by the principal investigator.\n* Any contraindication for undergoing magnetic resonance spectroscopy (MRS), such as the presence of metal implants, a cardiac pacemaker that is not compatible with MRS, or severe claustrophobia"}, 'identificationModule': {'nctId': 'NCT02593318', 'acronym': 'TOAD', 'briefTitle': "Trial of Oxaloacetate in Alzheimer's Disease (TOAD)", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Trial of Oxaloacetate in Alzheimer's Disease (TOAD)", 'orgStudyIdInfo': {'id': 'STUDY00002242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - Oxaloacetate (OAA) 1 gram/day', 'description': 'Participants take 1 gram of OAA per day for period of 4 weeks', 'interventionNames': ['Drug: Oxaloacetate (OAA) 1g']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Oxaloacetate (OAA)2 gram/day', 'description': 'Participants take 2 grams of OAA per day for period of 4 weeks', 'interventionNames': ['Drug: Oxaloacetate (OAA) 2g']}], 'interventions': [{'name': 'Oxaloacetate (OAA) 1g', 'type': 'DRUG', 'otherNames': ['Oxobutanedioic acid', 'Oxaloacetic acid', 'Oxalacetic acid', '2-Oxosuccinic acid', 'Ketosuccinic acid'], 'description': 'Pills to be taken orally in 500mg dose two times per day', 'armGroupLabels': ['Part 1 - Oxaloacetate (OAA) 1 gram/day']}, {'name': 'Oxaloacetate (OAA) 2g', 'type': 'DRUG', 'otherNames': ['Oxobutanedioic acid', 'Oxaloacetic acid', 'Oxalacetic acid', '2-Oxosuccinic acid', 'Ketosuccinic acid'], 'description': 'Pills to be taken orally in 1000mg dose two times per day.', 'armGroupLabels': ['Part 2 - Oxaloacetate (OAA)2 gram/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Russell Swerdlow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russell Swerdlow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gene and Marge Sweeney Professor of Neurology', 'investigatorFullName': 'Russell Swerdlow', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}