Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-30 @ 3:14 PM
Study NCT ID:
NCT01044758
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2010-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
Sponsor:
Organization:
Raw JSON
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'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gkrauss@jhmi.edu', 'phone': '(410) 955-2822', 'title': 'Gregory Krauss, M.D.', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'aMCI_62.5', 'description': '62.5 mg levetiracetam twice daily for two weeks', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 5, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'aMCI_62.5 Placebo', 'description': '62.5 mg placebo comparator (placebo capsule twice daily for two weeks)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'aMCI_125', 'description': '125 mg levetiracetam twice daily for two weeks', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'aMCI_125 Placebo', 'description': '125 mg placebo comparator (placebo capsule twice daily for two weeks)', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'aMCI_250', 'description': '250 mg levetiracetam twice daily for two weeks', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 5, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'aMCI_250 Placebo', 'description': '250 mg placebo comparator (placebo capsule twice daily for two weeks)', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 7, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Age Matched Control', 'description': 'placebo capsule twice daily for two weeks', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'aMCI_62.5', 'description': '62.5 mg levetiracetam twice daily for two weeks'}, {'id': 'OG001', 'title': 'aMCI_62.5 Placebo', 'description': '62.5mg levetiracetam placebo comparator'}, {'id': 'OG002', 'title': 'aMCI_125', 'description': '125 mg Levetiracetam twice daily for two weeks.'}, {'id': 'OG003', 'title': 'aMCI_125 Placebo', 'description': '125mg levetiracetam placebo comparator'}, {'id': 'OG004', 'title': 'aMCI_250', 'description': '250mg levetiracetam twice daily for two weeks'}, {'id': 'OG005', 'title': 'aMCI_250 Placebo', 'description': '250mg levetiracetam placebo comparator'}, {'id': 'OG006', 'title': 'Age Matched Control', 'description': 'Placebo capsule twice daily for two weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1203', 'spread': '0.3475', 'groupId': 'OG000'}, {'value': '0.4353', 'spread': '0.2215', 'groupId': 'OG001'}, {'value': '-0.2238', 'spread': '0.1747', 'groupId': 'OG002'}, {'value': '0.8814', 'spread': '0.3798', 'groupId': 'OG003'}, {'value': '0.3928', 'spread': '0.2366', 'groupId': 'OG004'}, {'value': '0.4825', 'spread': '0.1954', 'groupId': 'OG005'}, {'value': '-.02507', 'spread': '.2238', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.', 'unitOfMeasure': 'mean beta coefficient', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'aMCI_62.5', 'description': '62.5mg levetiracetam twice daily for two weeks'}, {'id': 'OG001', 'title': 'aMCI_62.5 Placebo', 'description': '62.6mg levetiracetam placebo comparator'}, {'id': 'OG002', 'title': 'aMCI_125', 'description': '125mg levetiracetam twice daily for two weeks'}, {'id': 'OG003', 'title': 'aMCI_125 Placebo', 'description': '125mg levetiracetam placebo comparator'}, {'id': 'OG004', 'title': 'aMCI_250', 'description': '250mg levetiracetam twice daily for two weeks'}, {'id': 'OG005', 'title': 'aMCI_250 Placebo', 'description': '250mg levetiracetam placebo comparator'}, {'id': 'OG006', 'title': 'Age Matched Control', 'description': 'Placebo capsule twice daily for two weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '4', 'groupId': 'OG000'}, {'value': '33', 'spread': '5', 'groupId': 'OG001'}, {'value': '33', 'spread': '5', 'groupId': 'OG002'}, {'value': '28', 'spread': '4', 'groupId': 'OG003'}, {'value': '34', 'spread': '4', 'groupId': 'OG004'}, {'value': '31', 'spread': '3', 'groupId': 'OG005'}, {'value': '44', 'spread': '4', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance.', 'unitOfMeasure': 'percent correct recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'aMCI_62.5mg Drug First, Then Placebo', 'description': 'Amnestic MCI:\n\n62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'FG001', 'title': 'aMCI_Placebo First, Then 62.5mg Drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)'}, {'id': 'FG002', 'title': 'aMCI_125mg Drug First, Then Placebo', 'description': 'Amnestic MCI:\n\n125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'FG003', 'title': 'aMCI_Placebo First, Then 125mg Drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)'}, {'id': 'FG004', 'title': 'aMCI_250mg Drug First, Then Placebo', 'description': 'Amnestic MCI:\n\n250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'FG005', 'title': 'aMCI_Placebo First, Then 250mg Drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)'}, {'id': 'FG006', 'title': 'Control_Placebo First, Then Placebo', 'description': 'Healthy control:\n\nplacebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '10'}]}]}], 'preAssignmentDetails': 'Data for the 125mg BID treatment cohort was collected first. Analysis showed no effects of treatment order. As a result, data was collapsed and analyzed irrespective of order across all doses. All subsequent data analyses are thus provided collapsed across treatment orders in all reporting on this study, including the results reported here.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '71', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'aMCI_62.5mg Drug First, Then Placebo', 'description': 'Amnestic MCI:\n\n62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'BG001', 'title': 'aMCI_Placebo First, Then 62.5mg Drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)'}, {'id': 'BG002', 'title': 'aMCI_125mg Drug First, Then Placebo', 'description': 'Amnestic MCI:\n\n125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'BG003', 'title': 'aMCI_Placebo First, Then 125mg Drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)'}, {'id': 'BG004', 'title': 'aMCI_250mg Drug First, Then Placebo', 'description': 'Amnestic MCI:\n\n250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'BG005', 'title': 'aMCI_Placebo First, Then 250mg Drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)'}, {'id': 'BG006', 'title': 'Control_Placebo First, Then Placebo', 'description': 'Healthy control\n\nplacebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '64', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '41', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '71', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2010-01-07', 'resultsFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-19', 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI', 'timeFrame': '2 weeks', 'description': 'Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.'}], 'secondaryOutcomes': [{'measure': 'Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task', 'timeFrame': '2 weeks', 'description': 'Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Amnestic Mild Cognitive Impairment', 'Functional Magnetic Resonance Imaging', 'Levetiracetam', 'Keppra', 'Medial Temporal Lobe', 'Memory Impairment', "Alzheimer's Disease", 'AD'], 'conditions': ['Mild Cognitive Impairment (MCI)']}, 'referencesModule': {'references': [{'pmid': '18802001', 'type': 'BACKGROUND', 'citation': "Busche MA, Eichhoff G, Adelsberger H, Abramowski D, Wiederhold KH, Haass C, Staufenbiel M, Konnerth A, Garaschuk O. Clusters of hyperactive neurons near amyloid plaques in a mouse model of Alzheimer's disease. Science. 2008 Sep 19;321(5896):1686-9. doi: 10.1126/science.1162844."}, {'pmid': '18356518', 'type': 'BACKGROUND', 'citation': 'Bakker A, Kirwan CB, Miller M, Stark CE. Pattern separation in the human hippocampal CA3 and dentate gyrus. Science. 2008 Mar 21;319(5870):1640-2. doi: 10.1126/science.1152882.'}, {'pmid': '17785178', 'type': 'BACKGROUND', 'citation': "Palop JJ, Chin J, Roberson ED, Wang J, Thwin MT, Bien-Ly N, Yoo J, Ho KO, Yu GQ, Kreitzer A, Finkbeiner S, Noebels JL, Mucke L. Aberrant excitatory neuronal activity and compensatory remodeling of inhibitory hippocampal circuits in mouse models of Alzheimer's disease. Neuron. 2007 Sep 6;55(5):697-711. doi: 10.1016/j.neuron.2007.07.025."}, {'pmid': '11756667', 'type': 'BACKGROUND', 'citation': 'Sperling R, Greve D, Dale A, Killiany R, Holmes J, Rosas HD, Cocchiarella A, Firth P, Rosen B, Lake S, Lange N, Routledge C, Albert M. Functional MRI detection of pharmacologically induced memory impairment. Proc Natl Acad Sci U S A. 2002 Jan 8;99(1):455-60. doi: 10.1073/pnas.012467899. Epub 2001 Dec 26.'}, {'pmid': '16033897', 'type': 'BACKGROUND', 'citation': 'Wilson IA, Ikonen S, Gallagher M, Eichenbaum H, Tanila H. Age-associated alterations of hippocampal place cells are subregion specific. J Neurosci. 2005 Jul 20;25(29):6877-86. doi: 10.1523/JNEUROSCI.1744-05.2005.'}, {'pmid': '17046075', 'type': 'BACKGROUND', 'citation': 'Wilson IA, Gallagher M, Eichenbaum H, Tanila H. Neurocognitive aging: prior memories hinder new hippocampal encoding. Trends Neurosci. 2006 Dec;29(12):662-70. doi: 10.1016/j.tins.2006.10.002. Epub 2006 Oct 13.'}, {'pmid': '20032967', 'type': 'BACKGROUND', 'citation': 'Koh MT, Haberman RP, Foti S, McCown TJ, Gallagher M. Treatment strategies targeting excess hippocampal activity benefit aged rats with cognitive impairment. Neuropsychopharmacology. 2010 Mar;35(4):1016-25. doi: 10.1038/npp.2009.207. Epub 2009 Dec 23.'}]}, 'descriptionModule': {'briefSummary': "This research is being done to find out if daily use of the drug levetiracetam can improve memory function in individuals with memory problems like those associated with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD).", 'detailedDescription': "Increasing research is focused on conditions that precede the clinical diagnosis of Alzheimer's disease (AD) in order to detect patients at risk for early intervention. One such condition is mild cognitive impairment (MCI). Functional magnetic resonance imaging (fMRI) studies in this group of patients have reported increased activation in the Medial Temporal Lobe (MTL) during performance of memory tasks. The functional significance of increased activation is unclear. One possibility is that greater activity reflects the increased effort needed in order to maintain performance, and as such would be a compensatory response. An alternative possibility is that increased activation reflects aberrant physiology related to the disease process itself and as such would be a sign of greater underlying disease severity and would interfere with brain function.\n\nData in animal models suggest the possibility that low dose levetiracetam (well-tolerated anti-convulsant) treatment may reduce the observed hyperactivity and improve memory performance among individuals with MCI. The investigators are therefore conducting a within-subjects trial of 8 weeks duration, involving 144 subjects and low dose treatment with levetiracetam. During the course of the study, each subject may receive both drug and placebo for two weeks, with the order of administering those treatments counterbalanced. Cognitive testing and fMRI imaging will be obtained after 2-weeks on drug/placebo. The overall goal of the study is to determine if treatment of MCI subjects with low dose levetiracetam reduces hyperactivity within the MTL and improves memory performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All: English as a first language; right handed; able to complete written informed consent.\n* MCI subjects: In addition to above, must meet criteria for amnestic Mild Cognitive Impairment (MCI). This includes a memory complaint corroborated by an informant; impaired memory function for age and educational level; preserved general cognitive function; intact abilities of daily living; no clinical dementia.\n* Age matched Controls: Must have memory and cognitive status that is normal for their age.\n\nExclusion Criteria:\n\n* Familial Alzheimer's Disease (AD) due to known genetic mutations\n* AD with Parkinsonian features; major psychiatric or behavioral disorders (e.g. depression, agitation, psychosis, manic-depressive disorder)\n* Primary or metastatic intracranial neoplasm\n* History of severe head trauma\n* Intra-cerebral hemorrhage\n* Seizure disorder\n* Hemispheric stroke\n* Presence of a progressive central nervous system disease\n* Presence of lacunar infarcts\n* Medical contraindications to MRI including cardiac pacemaker, presence of intraocular or intracranial metallic objects\n* Any known allergy to levetiracetam or behavioral problems that are a contraindication to taking Levetiracetam (e.g. agitation)\n* Prescribed use of anti-seizure medications."}, 'identificationModule': {'nctId': 'NCT01044758', 'briefTitle': 'Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI', 'orgStudyIdInfo': {'id': 'NA_00030573'}, 'secondaryIdInfos': [{'id': 'RC2AG036419', 'link': 'https://reporter.nih.gov/quickSearch/RC2AG036419', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aMCI_62.5mg drug first, then placebo', 'description': 'Amnestic MCI:\n\n62.5mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)', 'interventionNames': ['Drug: Levetiracetam 62.5mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'aMCI_Placebo first, then 62.5mg drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 62.5mg levetiracetam twice daily (two weeks)', 'interventionNames': ['Drug: Levetiracetam 62.5mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'aMCI_125mg drug first, then placebo', 'description': 'Amnestic MCI:\n\n125mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)', 'interventionNames': ['Drug: Levetiracetam 125mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'aMCI_Placebo first, then 125mg drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 125mg levetiracetam twice daily (two weeks)', 'interventionNames': ['Drug: Levetiracetam 125mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'aMCI_250mg drug first, then placebo', 'description': 'Amnestic MCI: 250mg levetiracetam twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)', 'interventionNames': ['Drug: Levetiracetam 250mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'aMCI_Placebo first, then 250mg drug', 'description': 'Amnestic MCI:\n\nPlacebo capsule twice daily (two weeks), washout (4 weeks), and 250mg levetiracetam twice daily (two weeks)', 'interventionNames': ['Drug: Levetiracetam 250mg', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control_Placebo first, then placebo', 'description': 'Healthy control:\n\nplacebo capsule twice daily (two weeks), washout (4 weeks), and placebo capsule twice daily (two weeks)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levetiracetam 62.5mg', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': '62.5mg twice daily (2 weeks)', 'armGroupLabels': ['aMCI_62.5mg drug first, then placebo', 'aMCI_Placebo first, then 62.5mg drug']}, {'name': 'Levetiracetam 125mg', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': '125mg twice daily (2 weeks)', 'armGroupLabels': ['aMCI_125mg drug first, then placebo', 'aMCI_Placebo first, then 125mg drug']}, {'name': 'Levetiracetam 250mg', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': '250mg twice daily (2 weeks)', 'armGroupLabels': ['aMCI_250mg drug first, then placebo', 'aMCI_Placebo first, then 250mg drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo capsule twice daily (2 weeks)', 'armGroupLabels': ['Control_Placebo first, then placebo', 'aMCI_125mg drug first, then placebo', 'aMCI_250mg drug first, then placebo', 'aMCI_62.5mg drug first, then placebo', 'aMCI_Placebo first, then 125mg drug', 'aMCI_Placebo first, then 250mg drug', 'aMCI_Placebo first, then 62.5mg drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Gregory L Krauss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}