Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-31 @ 3:21 AM
Study NCT ID:
NCT00539305
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2007-10-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hormone and Information Processing Study
Sponsor:
Organization:
Raw JSON
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The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Vigor-Activity'}, {'type': 'PRIMARY', 'title': 'Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl\n\ntestosterone gel : 50-100mg applied topically daily for six months'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo gel : applied topically daily for six months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (Change from Baseline)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (Change from Baseline)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Geriatric Depression Scale (GDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl\n\ntestosterone gel : 50-100mg applied topically daily for six months'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo gel : applied topically daily for six months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (Change from Baseline)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (Change from Baseline)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl\n\ntestosterone gel : 50-100mg applied topically daily for six months'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo gel : applied topically daily for six months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '70.7', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '85.6', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (Change from Baseline)', 'categories': [{'measurements': [{'value': '15.0', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (Change from Baseline)', 'categories': [{'measurements': [{'value': '6.4', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl\n\ntestosterone gel : 50-100mg applied topically daily for six months'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Placebo gel : applied topically daily for six months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Substance Use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl\n\ntestosterone gel : 50-100mg applied topically daily for six months'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Placebo gel : applied topically daily for six months'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '70.0', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-10', 'studyFirstSubmitDate': '2007-10-03', 'resultsFirstSubmitDate': '2013-03-15', 'studyFirstSubmitQcDate': '2007-10-03', 'lastUpdatePostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-10', 'studyFirstPostDateStruct': {'date': '2007-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioral & Mood Measure: Profile of Mood States (POMS)', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.'}, {'measure': 'Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test', 'timeFrame': 'Baseline, 3 and 6 months', 'description': 'Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.'}, {'measure': 'Short-Form Health Survey (SF-36)', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['selective androgen receptor modulators (SARMs)', 'hormone replacement therapy', 'age-associated cognitive decline', 'testosterone supplementation'], 'conditions': ['Mild Cognitive Impairment', "Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '11445632', 'type': 'BACKGROUND', 'citation': 'Cherrier MM, Asthana S, Plymate S, Baker L, Matsumoto AM, Peskind E, Raskind MA, Brodkin K, Bremner W, Petrova A, LaTendresse S, Craft S. Testosterone supplementation improves spatial and verbal memory in healthy older men. Neurology. 2001 Jul 10;57(1):80-8. doi: 10.1212/wnl.57.1.80.'}, {'pmid': '15668427', 'type': 'BACKGROUND', 'citation': 'Cherrier MM, Matsumoto AM, Amory JK, Ahmed S, Bremner W, Peskind ER, Raskind MA, Johnson M, Craft S. The role of aromatization in testosterone supplementation: effects on cognition in older men. Neurology. 2005 Jan 25;64(2):290-6. doi: 10.1212/01.WNL.0000149639.25136.CA.'}, {'pmid': '15985573', 'type': 'BACKGROUND', 'citation': 'Cherrier MM, Matsumoto AM, Amory JK, Asthana S, Bremner W, Peskind ER, Raskind MA, Craft S. Testosterone improves spatial memory in men with Alzheimer disease and mild cognitive impairment. Neurology. 2005 Jun 28;64(12):2063-8. doi: 10.1212/01.WNL.0000165995.98986.F1.'}, {'pmid': '17145137', 'type': 'BACKGROUND', 'citation': 'Cherrier MM, Matsumoto AM, Amory JK, Johnson M, Craft S, Peskind ER, Raskind MA. Characterization of verbal and spatial memory changes from moderate to supraphysiological increases in serum testosterone in healthy older men. Psychoneuroendocrinology. 2007 Jan;32(1):72-9. doi: 10.1016/j.psyneuen.2006.10.008. Epub 2006 Dec 4.'}, {'pmid': '16344336', 'type': 'BACKGROUND', 'citation': 'Lu PH, Masterman DA, Mulnard R, Cotman C, Miller B, Yaffe K, Reback E, Porter V, Swerdloff R, Cummings JL. Effects of testosterone on cognition and mood in male patients with mild Alzheimer disease and healthy elderly men. Arch Neurol. 2006 Feb;63(2):177-85. doi: 10.1001/archneur.63.2.nct50002. Epub 2005 Dec 12.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.", 'detailedDescription': "Natural age related declines in testosterone (T) are associated with decreases in cognitive abilities independent of health status. Low T levels over time are associated with increased risk for developing Alzheimer's disease (AD). These findings suggest that men with low T levels are most at risk for age-related cognitive decline and AD and therefore most likely to benefit from T supplementation to prevent the development of AD or age-associated cognitive decline. The current study will assess cognition, mood, and cerebral spinal fluid (CSF) biomarker response to T supplementation in older men with mild cognitive impairment (MCI) and low T levels.\n\nParticipants will be randomized to either receive T treatment or a placebo for six months. Participants will come in for about five visits within the span of six months where they will complete cognitive \\& memory tests, fill out mood questionnaires, and have their blood drawn to monitor the medication level. A sample of blood will also be taken at one visit to test for apolipoprotein E (APOE), which is a genetic risk factor associated with AD. Participants will have the option to get a spinal tap in order to measure biological markers associated with Alzheimer's disease including beta-amyloid 1-40, 42, total-tau, and phosphorylated-tau-181-231. This will require an additional two visits."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male 60-90 years of age\n* Diagnosis of mild cognitive impairment (MCI)\n* Low testosterone level\n* Primary language is English\n* Availability of an informant who knows the participant well enough to answer questions\n* Stable medications for the previous 3 months\n* Normal complete blood count (CBC), and no clinically significant blood chemistry\n* American Urological Association (AUA) symptom score less than or equal to 19\n* Body Mass Index (BMI) less than 33 and stable weight in the previous year\n\nExclusion Criteria:\n\n* Prior history of prostate cancer or prostate specific antigen level greater than 4.0ng/ml\n* Peripheral or vascular disease\n* Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per day), or other substance abuse\n* History of severe head injury (with loss of consciousness greater than 30 minutes)\n* Significant neurological illness, such as Parkinson's disease, seizure disorder, multiple sclerosis, major stoke\n* Smokes cigarettes\n* Major psychiatric illness, such as schizophrenia or bipolar disorder\n\nProhibited Medications:\n\n* Anti-convulsants\n* Anti-psychotics\n* Sedating antihistamines\n* Sedative/hypnotics\n* Benzodiazepines\n* Hormone or testosterone regimens\n* Gonadotropin-releasing hormone (GNRH) antagonists\n* Flutamide\n* Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more"}, 'identificationModule': {'nctId': 'NCT00539305', 'acronym': 'HIP', 'briefTitle': 'Hormone and Information Processing Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Testosterone Supplementation in Men With MCI', 'orgStudyIdInfo': {'id': '29975-A'}, 'secondaryIdInfos': [{'id': 'R01AG027156', 'link': 'https://reporter.nih.gov/quickSearch/R01AG027156', 'type': 'NIH'}, {'id': '1R01AG027156-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG027156-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study drug; testosterone transdermal gel', 'description': 'Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl', 'interventionNames': ['Drug: testosterone gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo gel']}], 'interventions': [{'name': 'testosterone gel', 'type': 'DRUG', 'otherNames': ['Solvay Testosterone Gel'], 'description': '50-100mg applied topically daily for six months', 'armGroupLabels': ['Study drug; testosterone transdermal gel']}, {'name': 'placebo gel', 'type': 'DRUG', 'description': 'applied topically daily for six months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care Systems', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Monique Cherrier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Monique Cherrier', 'investigatorAffiliation': 'University of Washington'}}}}