Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03482167
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
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Total brain blood flow was therefore assessed in all participants by MRI using pseudo-continuous arterial spin labeling (pCASL).'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritus', 'notes': 'Poison Ivy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 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'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Insomnia', 'notes': 'Sleep disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Heart palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'notes': 'panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cognitive Scores at Baseline and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}], 'classes': [{'title': 'CVLT3 Trial 1-5 Index Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96', 'spread': '4', 'groupId': 'OG000'}, {'value': '99', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'CVLT3 Trial 1-5 Index Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '3', 'groupId': 'OG000'}, {'value': '103', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'CVLT3 Delayed Recall Index Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'spread': '3', 'groupId': 'OG000'}, {'value': '93', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'CVLT3 Delayed Recall Index Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'spread': '4', 'groupId': 'OG000'}, {'value': '100', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'CVLT3 Total Recall Index Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'spread': '4', 'groupId': 'OG000'}, {'value': '96', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'CVLT3 Total Recall Index Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'spread': '3', 'groupId': 'OG000'}, {'value': '101', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Logical Memory I Total Raw Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '1', 'groupId': 'OG000'}, {'value': '20', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Logical Memory I Total Raw Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'spread': '1', 'groupId': 'OG000'}, {'value': '25', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Logical Memory II Total Raw Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'spread': '1', 'groupId': 'OG000'}, {'value': '15', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Logical Memory II Total Raw Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'spread': '2', 'groupId': 'OG000'}, {'value': '19', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Logical Memory II Recognition Total Raw Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'spread': '1', 'groupId': 'OG000'}, {'value': '22', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Logical Memory II Recognition Total Raw Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'spread': '1', 'groupId': 'OG000'}, {'value': '24', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Visual Reproduction I Total Raw Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '1', 'groupId': 'OG000'}, {'value': '29', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Visual Reproduction I Total Raw Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'spread': '2', 'groupId': 'OG000'}, {'value': '30', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Visual Reproduction II Total Raw Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'spread': '2', 'groupId': 'OG000'}, {'value': '17', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Visual Reproduction II Total Raw Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'spread': '2', 'groupId': 'OG000'}, {'value': '18', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Visual Reproduction II Recognition Total Raw Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '5', 'spread': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'WMS-IV Visual Reproduction II Recognition Total Raw Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '5', 'spread': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'NIH Toolbox Fluid Cognition Score (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87', 'spread': '2', 'groupId': 'OG000'}, {'value': '84', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'NIH Toolbox Fluid Cognition Score (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'spread': '3', 'groupId': 'OG000'}, {'value': '84', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Primary outcome was a change from baseline in any domain of cognitive function. For all outcomes, a higher score indicates better cognitive function:\n\n1. California Verbal Learning Test III (CVLT-III) Index Scores. Ability learn and recall a list of words over 5 trials and again after a 20 minute delay. Each Index Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145).\n2. Wechsler Memory Scale IV (WMS-IV) Raw Scores.\n\n * Logical Memory I \\& II: Range = 0-50\n * Logical Memory II Recognition: Range = 0-30\n * Visual Reproduction I \\& II: Range = 0-43\n * Visual Reproduction II Recognition Score: Range = 0-7\n3. NIH Toolbox Fluid Composite Score. Composite Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145) - based on several tests of fluid and crystallized cognition (episodic memory, attention, working memory, processing speed, executive function and language abilities).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases analyzed for select cognitive tests differs from overall number analyzed due to missing data.'}, {'type': 'SECONDARY', 'title': 'Cerebrovascular Reactivity at Baseline and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}], 'classes': [{'title': 'Percent change in MCA velocity per mmHg change in ETCO2 - Baseline', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Percent change in MCA velocity per mmHg change in ETCO2 - Week 12', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Relative (percent) change in blood velocity of the middle cerebral artery (MCA) per mmHg change in end-tidal carbon dioxide (ETCO2) during a brief period of hypercapnia.\n\nHypercapnia was induced by prospective end-tidal targeting (RespirAct, Thornhill Medical) in which a target change in end-tidal CO2 of +9mmHg was set. Data were only analyzed if ETCO2 changed by at least 6mmHg. All data were then normalized to the absolute change in ETCO2.', 'unitOfMeasure': '% change in MCAv (m/sec) per mmHg ETCO2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Brain Blood Flow at Baseline and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Total brain blood flow assessed by pseudo-continuous arterial spin labeling (pcASL). Total brain blood flow is measured in milliliters of blood per minute per 100 grams of brain tissue.', 'unitOfMeasure': 'ml/min/100g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases analyzed for select cognitive tests differs from overall number analyzed due to missing data.'}, {'type': 'SECONDARY', 'title': 'Aortic Stiffness at Baseline and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Carotid-femoral pulse wave velocity (CFPWV)', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases analyzed for select cognitive tests differs from overall number analyzed due to missing data.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure at Baseline and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}], 'classes': [{'title': 'Systolic (Baseline)', 'categories': [{'measurements': [{'value': '124', 'spread': '3', 'groupId': 'OG000'}, {'value': '132', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Systolic (Week 12)', 'categories': [{'measurements': [{'value': '123', 'spread': '3', 'groupId': 'OG000'}, {'value': '127', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic (Baseline)', 'categories': [{'measurements': [{'value': '70', 'spread': '2', 'groupId': 'OG000'}, {'value': '74', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic (Week 12)', 'categories': [{'measurements': [{'value': '72', 'spread': '2', 'groupId': 'OG000'}, {'value': '73', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neurovascular Coupling at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Cerebrovascular reactivity to cognitive tasks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functional Brain Connectivity at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'functional brain connectivity assessed by MRI', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neuronal Activation at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Functional MRI (fMRI) to cognitive task', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Brain Volume at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'White and grey matter volume assessed by structural MRI', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'FG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}], 'periods': [{'title': 'Allocated to Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Received Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were screened for inclusion in this study at the University of Delaware between March 20, 2019 - August 21, 2023.', 'preAssignmentDetails': 'A total of 64 participants were consented into this study. Of these, 13 participants were withdrawn prior to randomization. Reasons for withdrawal inlcluded not meeting eligibility criteria (N = 7), failure to comply with study requirements (N = 1), voluntarily withdrawal by the participant (N = 2), or if a participant was lost to followup (N = 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'BG001', 'title': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily\n\nNiagen®: 250 mg capsules (4 capsules daily)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'spread': '7', 'groupId': 'BG000'}, {'value': '72', 'spread': '8', 'groupId': 'BG001'}, {'value': '72', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'APOE ε4 Carrier', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'One or more copy of the APOE ε4 allele', 'unitOfMeasure': 'Participants'}, {'title': 'APOE Genotype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'ε2/ε2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'ε2/ε3', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'ε2/ε4', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'ε3/ε3', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'ε3/ε4', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'ε4/ε4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mini Mental State Exam (MMSE)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'spread': '2', 'groupId': 'BG000'}, {'value': '26', 'spread': '2', 'groupId': 'BG001'}, {'value': '27', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total Score on the MMSE ranges between 0-30, with a higher score indicative of better cognitive function. A Total Score below 20 is indicative of moderate to severe dementia and was used a cutoff for inclusion in this study.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Dementia Rating - Global Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.4', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.4', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Global Clinical Dementia Rating (CDR) Score is a calculated weighted score derived from the following six "box scores": 1) Memory, 2) Orientation, 3) Judgment and problem-solving, 4) Community affairs, 5) Home and hobbies, and 6) Personal care. Global CDR Score is used to assess level of impairment and severity of dementia based on the following scale:\n\n0 = Normal; 0.5 = Very Mild Dementia; 1 = Mild Dementia; 2 = Moderate Dementia; 3 = Severe Dementia', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Revised Hopkins Verbal Learning Test (HVLT-R) Total Recall Memory', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '8', 'groupId': 'BG000'}, {'value': '38', 'spread': '8', 'groupId': 'BG001'}, {'value': '39', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Revised Hopkins Verbal Learning Test (HVLT-R) assesses verbal learning and memory, immediate recall, delayed recall, and delayed recognition. Total Recall T-score was used in the determination of mild cognitive impairment (MCI). A T-score of 50 represents the population mean with a standard deviation of 10. A T-score \\<50 indicates below average cognitive function and a T-score ≤ 35 is potentially indicative of MCI.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Revised Brief Visuospatial Memory Test (BVMT-R) Total Recall Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '13', 'groupId': 'BG000'}, {'value': '33', 'spread': '8', 'groupId': 'BG001'}, {'value': '35', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Revised Brief Visuospatial Memory Test (BVMT-R) assesses visuospatial memory and includes an immediate and delayed recall. Total Recall T-score was used in the determination of mild cognitive impairment (MCI). A T-score of 50 represents the population mean with a standard deviation of 10. A T-score \\<50 indicates below average cognitive function and a T-score ≤ 35 is potentially indicative of MCI.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Screening for MCI status occurred in-person until March 2020 when the study was temporarily stopped due to the COVID-19 pandemic. Prior to the pandemic, we used the BVMT, in-person, in our screening pipeline for MCI status. After the pandemic, we began doing most of our screenings using online video conferencing. Because the BVMT cannot easily be administered online, we switched to using the WMS Logical Memory Test.'}, {'title': 'Revised Wechsler Memory Scale (WMS-R) - Logical Memory I', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'spread': '3', 'groupId': 'BG000'}, {'value': '8', 'spread': '3', 'groupId': 'BG001'}, {'value': '8', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Logical Memory I (immediate recall) is a subset of the Wechsler Memory Scale and assesses the ability to immediately recall aspects of a story. Scaled scores range from 1-19 and are derived from 100 normative cases within a specific age band. The scaled score is based on a normal distribution with a mean of 10 and a standard deviation of 3. A scaled score of at least 1.5 standard deviations below the mean is potentially indicative of MCI.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Screening for MCI status occurred in-person until March 2020 when the study was temporarily stopped due to the COVID-19 pandemic. Prior to the pandemic, we used the BVMT, in-person, in our screening pipeline for MCI status. After the pandemic, we began doing most of our screenings using online video conferencing. Because the BVMT cannot easily be administered online, we switched to using the WMS Logical Memory Test.'}], 'populationDescription': 'Criteria for amnestic mild cognitive impairment (MCI) included lack of dementia and at least one memory score ≤ 1.5 standard deviations from the mean.\n\nOne (1) participant allocated to placebo was withdrawn prior to treatment due to disclosure of prior cancer history, which was a stated exclusion criterion.\n\nTwo (2) participants allocated to NR were withdrawn prior to starting treatment due to disclosure of prior cancer history, which was a stated exclusion criterion.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-14', 'size': 344557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-08T11:57', 'hasProtocol': True}, {'date': '2023-06-20', 'size': 438406, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-08T11:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2018-02-14', 'resultsFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2018-03-22', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-02', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neurovascular Coupling at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Cerebrovascular reactivity to cognitive tasks'}, {'measure': 'Functional Brain Connectivity at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'functional brain connectivity assessed by MRI'}, {'measure': 'Neuronal Activation at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Functional MRI (fMRI) to cognitive task'}, {'measure': 'Brain Volume at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'White and grey matter volume assessed by structural MRI'}], 'primaryOutcomes': [{'measure': 'Cognitive Scores at Baseline and Week 12', 'timeFrame': 'baseline and 12 weeks', 'description': 'Primary outcome was a change from baseline in any domain of cognitive function. For all outcomes, a higher score indicates better cognitive function:\n\n1. California Verbal Learning Test III (CVLT-III) Index Scores. Ability learn and recall a list of words over 5 trials and again after a 20 minute delay. Each Index Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145).\n2. Wechsler Memory Scale IV (WMS-IV) Raw Scores.\n\n * Logical Memory I \\& II: Range = 0-50\n * Logical Memory II Recognition: Range = 0-30\n * Visual Reproduction I \\& II: Range = 0-43\n * Visual Reproduction II Recognition Score: Range = 0-7\n3. NIH Toolbox Fluid Composite Score. Composite Score has a mean of 100 and a standard deviation of 15 based on normative dataset (Range = 55 - 145) - based on several tests of fluid and crystallized cognition (episodic memory, attention, working memory, processing speed, executive function and language abilities).'}], 'secondaryOutcomes': [{'measure': 'Cerebrovascular Reactivity at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Relative (percent) change in blood velocity of the middle cerebral artery (MCA) per mmHg change in end-tidal carbon dioxide (ETCO2) during a brief period of hypercapnia.\n\nHypercapnia was induced by prospective end-tidal targeting (RespirAct, Thornhill Medical) in which a target change in end-tidal CO2 of +9mmHg was set. Data were only analyzed if ETCO2 changed by at least 6mmHg. All data were then normalized to the absolute change in ETCO2.'}, {'measure': 'Total Brain Blood Flow at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Total brain blood flow assessed by pseudo-continuous arterial spin labeling (pcASL). Total brain blood flow is measured in milliliters of blood per minute per 100 grams of brain tissue.'}, {'measure': 'Aortic Stiffness at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Carotid-femoral pulse wave velocity (CFPWV)'}, {'measure': 'Blood Pressure at Baseline and 12 Weeks', 'timeFrame': 'baseline and 12 weeks', 'description': 'Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure', 'arterial stiffness', 'cerebrovascular function', 'cognitive function'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study will provide insight into whether a nutritional supplement, nicotinamide riboside (NR), improves memory and brain blood flow in older adults with low memory abilities. Overall, this project has the potential to identify a novel, safe and cost-effective strategy for decreasing age-related memory loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation;\n* age 60-90 years;\n* MMSE score \\>24 at time of initial consent;\n\nExclusion Criteria\n\n* blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function; estimated glomerular filtration rate using the MDRD prediction equation must be \\>30 ml/min/1.73 m2;\n* any clinically significant abnormal blood chemistry values as determined by the research nurse or NMPCC nurse practitioner;\n* major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);\n* neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, mild or severe traumatic brain injury, large vessel infarct);\n* concussion within last 2 years and ≥ 3 lifetime concussions;\n* current systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure);\n* prior history of any type of cancer;\n* substance abuse or dependence (DSM-V criteria);\n* current use of medications used to treat dementia (e.g., anticholinesterase drugs) or other drugs likely to affect cognition (e.g., anticholinergic drugs, long-acting benzodiazepines);\n* claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning\\*;\n* current smoking (including marijuana) within the past 3 months;\n* hospitalization as a result of COVID-19"}, 'identificationModule': {'nctId': 'NCT03482167', 'briefTitle': 'NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': '1079271'}, 'secondaryIdInfos': [{'id': 'K01AG054731', 'link': 'https://reporter.nih.gov/quickSearch/K01AG054731', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotinamide Riboside', 'description': 'Niagen® (ChromaDex, Inc.) 500 mg, twice daily', 'interventionNames': ['Drug: Niagen®']}], 'interventions': [{'name': 'Niagen®', 'type': 'DRUG', 'otherNames': ['nicotinamide riboside chloride'], 'description': '250 mg capsules (4 capsules daily)', 'armGroupLabels': ['Nicotinamide Riboside']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Neurovascular Aging Laboratory', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Christopher R Martens, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christopher Martens', 'investigatorAffiliation': 'University of Delaware'}}}}