Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-31 @ 11:23 PM
Study NCT ID:
NCT00768261
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Corticolimbic Degeneration and Treatment of Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}, {'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgc@northwestern.edu', 'phone': '(312) 926-2323', 'title': 'John G. Csernansky, MD', 'organization': 'Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Interpretation of results limited to evaluating overall effects in naturalistic groups undergoing 2 drug treatments;Insufficient subjects to determine possible existence of DAT patient subgroups showing drug-specific slowing of disease progression'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Very Mild to Mild DAT Untreated', 'description': 'Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Very Mild to Mild DAT Treated With Donepezil', 'description': 'Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.\n\nDonepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 Very Mild to Mild DAT Treated With the Combination', 'description': 'Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.\n\nMemantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.\n\nMemantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '4 Nondemented Comparison Subjects.', 'description': 'Group 4) nondemented comparison subjects.', 'otherNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Change of Hippocampal Volume Slope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 Very Mild to Mild DAT Untreated', 'description': 'Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine'}, {'id': 'OG001', 'title': '2 Very Mild to Mild DAT Treated With Donepezil', 'description': 'Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.\n\nDonepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.'}, {'id': 'OG002', 'title': '3 Very Mild to Mild DAT Treated With the Combination', 'description': 'Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.\n\nMemantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.\n\nMemantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects'}, {'id': 'OG003', 'title': '4 Nondemented Comparison Subjects.', 'description': 'Group 4) nondemented comparison subjects.'}], 'classes': [{'title': 'left hippocampal volume slope', 'categories': [{'measurements': [{'value': '-70.2418748', 'spread': '31.4801034', 'groupId': 'OG000'}, {'value': '-88.4738591', 'spread': '52.2621175', 'groupId': 'OG001'}, {'value': '-94.0768115', 'spread': '48.349487', 'groupId': 'OG002'}, {'value': '-46.9484805', 'spread': '83.5825530', 'groupId': 'OG003'}]}]}, {'title': 'right hippocampal volume slope', 'categories': [{'measurements': [{'value': '-99.9437062', 'spread': '65.1619838', 'groupId': 'OG000'}, {'value': '-94.3258652', 'spread': '44.7959659', 'groupId': 'OG001'}, {'value': '-125.0687876', 'spread': '72.5509442', 'groupId': 'OG002'}, {'value': '-80.0840066', 'spread': '130.3453711', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.095', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'df= 3,92'}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'unitOfMeasure': 'mm^3/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Improved', 'description': 'Response group by ADAS-Cog rates'}, {'id': 'OG001', 'title': 'Worsening', 'description': 'Response group by ADAS-Cog rates'}, {'id': 'OG002', 'title': 'Stable', 'description': 'Response group by ADAS-Cog rates'}], 'classes': [{'title': 'left hippocampal volume slope', 'categories': [{'measurements': [{'value': '-70', 'spread': '56', 'groupId': 'OG000'}, {'value': '-106', 'spread': '55', 'groupId': 'OG001'}, {'value': '-100', 'spread': '37', 'groupId': 'OG002'}]}]}, {'title': 'right hippocampal volume slope', 'categories': [{'measurements': [{'value': '-77', 'spread': '51', 'groupId': 'OG000'}, {'value': '-141', 'spread': '78', 'groupId': 'OG001'}, {'value': '-105', 'spread': '34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'There would be a treatment effect on the changes of hippocampal measures over time.\n\nRepeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'There would be a treatment effect on the changes of hippocampal measures over time.\n\nRepeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.30', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'There would be a treatment effect on the changes of hippocampal measures over time.\n\nRepeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0288', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'RM-ANOVA on hippocampal volume slope', 'statisticalMethod': 'Repeated Measures ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'two years', 'description': "The ADAS-Cog evaluates cognition and differentiates normal from impaired cognitive functioning. The total score is the summed number of errors in each task. The greater the impairment, the greater the score. We combined the dementia of the Alzheimer's type patients receiving all treatments together and grouped them into 3 subgroups according to the rates of change(roc) of their ADAS-Cog scores. To determine trends in hippocampal volume atrophy over time we compared the patients showing most negative ADAS-Cog rate of change (improving), patients with most positive ADAS-cog roc (worsening), patients with intermediate, near-zero ADAS-Cog roc (stable) .", 'unitOfMeasure': '(mm^3/year)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We combined the DAT patients who received any treatment (donepezil or combined) \\& used the annual roc in ADAS-Cog to equally separate them into 3 subgroups; improving (1/3 negative ADAS-Cog roc), stable (1/3 near-zero ADAS-Cog change) \\& worsening (1/3 positive ADAS-Cog change).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Very Mild to Mild DAT Untreated', 'description': 'Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine'}, {'id': 'FG001', 'title': '2 Very Mild to Mild DAT Treated With Donepezil', 'description': 'Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.\n\nDonepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.'}, {'id': 'FG002', 'title': '3 Very Mild to Mild DAT Treated With the Combination', 'description': 'Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.\n\nMemantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.\n\nMemantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects'}, {'id': 'FG003', 'title': '4 Nondemented Comparison Subjects.', 'description': 'Group 4) nondemented comparison subjects.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "39 subjects enrolled in Group3.14 maps have passed inspection for quality and are included in final analysis. Subject data from a previously published study of donepezil(Wang et al.,2010) with 18 very mild dementia of the Alzheimer's type patients treated with donepezil,14 untreated with mild DAT, and 56 cognitively normal individuals are included."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1 Very Mild to Mild DAT Untreated', 'description': 'Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine'}, {'id': 'BG001', 'title': '2 Very Mild to Mild DAT Treated With Donepezil', 'description': 'Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with donepezil.\n\nDonepezil (Aricept®): 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.'}, {'id': 'BG002', 'title': '3 Very Mild to Mild DAT Treated With the Combination', 'description': 'Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of donepezil and memantine.\n\nMemantine (Namenda®): Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.\n\nMemantine (Namenda®): Initial dose of 10mg/day and increased to full dose of 20mg/day if no serious side-effects'}, {'id': 'BG003', 'title': '4 Nondemented Comparison Subjects.', 'description': 'Group 4) nondemented comparison subjects.'}, {'id': 'BG004', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Group 3; 39 subjects initially included. 8 subjects ineligible at initial assessment. 8 didn't have a follow-up MR scans for reasons; being deceased at the eos, refusal to scan, being unable to complete scanning due to discomfort. 5 subjects excluded due to poor baseline MR quality. 4 more scans excluded due to poor longitudinal mapping quality"}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2008-08-26', 'size': 612856, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-03-15T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2008-10-07', 'resultsFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-09', 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Change of Hippocampal Volume Slope', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': "Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change", 'timeFrame': 'two years', 'description': "The ADAS-Cog evaluates cognition and differentiates normal from impaired cognitive functioning. The total score is the summed number of errors in each task. The greater the impairment, the greater the score. We combined the dementia of the Alzheimer's type patients receiving all treatments together and grouped them into 3 subgroups according to the rates of change(roc) of their ADAS-Cog scores. To determine trends in hippocampal volume atrophy over time we compared the patients showing most negative ADAS-Cog rate of change (improving), patients with most positive ADAS-cog roc (worsening), patients with intermediate, near-zero ADAS-Cog roc (stable) ."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dementia of the Alzheimer type'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this research is to determine if there is a relationship between your symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.', 'detailedDescription': 'In this study we will be using Memantine (Namenda®) in an investigational fashion with individuals with very mild to mild dementia. Donepezil (Aricept®) is approved by the Food and Drug Administration for the treatment of Alzheimers disease. Memantine (Namenda®) is currently approved by the Food and Drug Administration for moderate and severe dementia only. This study may be instrumental in the development of a new therapy for others with similar conditions, and to determine whether Memantine (Namenda®) will be helpful to individuals with very mild to mild dementia.\n\nSpecific Aim 1. To determine what neuroanatomical measures are most strongly correlated with the progression of clinical and cognitive deficits in patients with dementia of the Alzheimer type (DAT). To accomplish this aim, we will use high-resolution magnetic resonance (MR) imaging and the tools of computational anatomy to assess changes in the structure of selected subcortical (e.g., hippocampus) and cortical (e.g., parahippocampal gyrus and cingulate gyrus) structure along with clinical and cognitive measures of dementia severity in subjects with very mild-to-mild DAT. Specific Aim 2 - To determine whether cholinesterase inhibitors and memantine can slow disease progression in DAT subjects. To accomplish this aim, we will use MR imaging and the tools of computational anatomy to compare the rate of change in the neuroanatomical measures listed above in 1) untreated DAT subjects, 2) DAT subjects treated with donepezil alone, and 3) DAT subjects treated with the combination of donepezil and memantine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: 1) meets National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) Alzheimer's criteria for dementia of the Alzheimer's type (DAT), 2) Clinical Dementia Rating (CDR) score of 0.5 or 1, 3) 50-80 years of age, 4) able to give informed consent or has a primary caregiver or legal guardian, who can give informed consent.\n\nExclusion Criteria: 1) other psychiatric (e.g., depression) or neurological (e.g., CVA) disorders that would confound the assessment of dementia symptoms, 2) history of loss of consciousness, and 3) unstable or severe medical illness (e.g., hepatotoxicity) that would make donepezil or memantine treatment or participation in other aspects of the study unsafe."}, 'identificationModule': {'nctId': 'NCT00768261', 'briefTitle': 'Corticolimbic Degeneration and Treatment of Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Corticolimbic Degeneration and Treatment of Dementia', 'orgStudyIdInfo': {'id': '5R01MH060883-06', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH060883-06', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Very Mild to Mild DAT Untreated', 'description': 'Group 1) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are untreated with either cholinesterase inhibitors or memantine'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Very Mild-Mild DAT Treated W/ Donepezil', 'description': 'Group 2) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with Donepezil (Aricept®).', 'interventionNames': ['Drug: Donepezil (Aricept®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Very Mild-Mild DAT Treated W/Combination', 'description': 'Group 3) subjects with very mild (CDR 0.5) to mild (CDR 1) DAT that are treated with the combination of Donepezil (Aricept®) and Memantine (Namenda®)', 'interventionNames': ['Drug: Memantine (Namenda®)', 'Drug: Donepezil (Aricept®)']}, {'type': 'NO_INTERVENTION', 'label': 'Nondemented Comparison Subjects', 'description': 'Group 4) nondemented comparison subjects.'}], 'interventions': [{'name': 'Memantine (Namenda®)', 'type': 'DRUG', 'otherNames': ['Namenda'], 'description': 'Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.', 'armGroupLabels': ['Very Mild-Mild DAT Treated W/Combination']}, {'name': 'Donepezil (Aricept®)', 'type': 'DRUG', 'otherNames': ['Aricept'], 'description': '5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.', 'armGroupLabels': ['Very Mild-Mild DAT Treated W/ Donepezil', 'Very Mild-Mild DAT Treated W/Combination']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}