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| ID | Type | Description | Link |
|---|---|---|---|
| K01AG054731 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo |
|
| Nicotinamide Riboside | Experimental | Niagen® (ChromaDex, Inc.) 500 mg, twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niagen® | Drug | 250 mg capsules (4 capsules daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Scores at Baseline and Week 12 | Primary outcome was a change from baseline in any domain of cognitive function. For all outcomes, a higher score indicates better cognitive function:
| baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrovascular Reactivity at Baseline and 12 Weeks | 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. Hypercapnia 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 | Description | Time Frame |
|---|---|---|
| Neurovascular Coupling at Baseline and 12 Weeks | Cerebrovascular reactivity to cognitive tasks | baseline and 12 weeks |
| Functional Brain Connectivity at Baseline and 12 Weeks | functional brain connectivity assessed by MRI |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christopher R Martens, Ph.D. | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurovascular Aging Laboratory | Newark | Delaware | 19713 | United States |
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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).
Participants were screened for inclusion in this study at the University of Delaware between March 20, 2019 - August 21, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: Placebo |
| FG001 | Nicotinamide Riboside | Niagen® (ChromaDex, Inc.) 500 mg, twice daily Niagen®: 250 mg capsules (4 capsules daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocated to Intervention |
|
| ||||||||||||||||||
| Received Intervention |
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Criteria for amnestic mild cognitive impairment (MCI) included lack of dementia and at least one memory score ≤ 1.5 standard deviations from the mean.
One (1) participant allocated to placebo was withdrawn prior to treatment due to disclosure of prior cancer history, which was a stated exclusion criterion.
Two (2) participants allocated to NR were withdrawn prior to starting treatment due to disclosure of prior cancer history, which was a stated exclusion criterion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Placebo |
| BG001 | Nicotinamide Riboside | Niagen® (ChromaDex, Inc.) 500 mg, twice daily Niagen®: 250 mg capsules (4 capsules daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cognitive Scores at Baseline and Week 12 | Primary outcome was a change from baseline in any domain of cognitive function. For all outcomes, a higher score indicates better cognitive function:
| Number of cases analyzed for select cognitive tests differs from overall number analyzed due to missing data. | Posted | Mean | Standard Error | score on a scale | baseline and 12 weeks |
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo: Placebo | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment | Poison Ivy |
Technical problems with ultrasound measures leading to unreliable or uninterpretable data in some participants. Total brain blood flow was therefore assessed in all participants by MRI using pseudo-continuous arterial spin labeling (pCASL).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher R. Martens, Ph.D. | University of Delaware | 302-831-7270 | cmartens@udel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2024 | Jan 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2023 | Jan 8, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
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Double-blind
| Placebo | Other | placebo |
|
| baseline and 12 weeks |
| Total Brain Blood Flow at Baseline and 12 Weeks | 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. | baseline and 12 weeks |
| Aortic Stiffness at Baseline and 12 Weeks | Carotid-femoral pulse wave velocity (CFPWV) | baseline and 12 weeks |
| Blood Pressure at Baseline and 12 Weeks | Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer. | baseline and 12 weeks |
| baseline and 12 weeks |
| Neuronal Activation at Baseline and 12 Weeks | Functional MRI (fMRI) to cognitive task | baseline and 12 weeks |
| Brain Volume at Baseline and 12 Weeks | White and grey matter volume assessed by structural MRI | baseline and 12 weeks |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| APOE ε4 Carrier | One or more copy of the APOE ε4 allele | Count of Participants | Participants |
|
| APOE Genotype | Count of Participants | Participants |
|
| Mini Mental State Exam (MMSE) | 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. | Mean | Standard Deviation | Units on a scale |
|
| Clinical Dementia Rating - Global Score | 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: 0 = Normal; 0.5 = Very Mild Dementia; 1 = Mild Dementia; 2 = Moderate Dementia; 3 = Severe Dementia | Mean | Standard Deviation | units on a scale |
|
| Revised Hopkins Verbal Learning Test (HVLT-R) Total Recall Memory | 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. | Mean | Standard Deviation | T-Score |
|
| Revised Brief Visuospatial Memory Test (BVMT-R) Total Recall Score | 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. | 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. | Mean | Standard Deviation | T-Score |
|
| Revised Wechsler Memory Scale (WMS-R) - Logical Memory I | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | Placebo Placebo: Placebo |
| OG001 | Nicotinamide Riboside | Niagen® (ChromaDex, Inc.) 500 mg, twice daily Niagen®: 250 mg capsules (4 capsules daily) |
|
|
| Secondary | Cerebrovascular Reactivity at Baseline and 12 Weeks | 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. Hypercapnia 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. | Posted | Mean | Standard Error | % change in MCAv (m/sec) per mmHg ETCO2 | baseline and 12 weeks |
|
|
|
| Secondary | Total Brain Blood Flow at Baseline and 12 Weeks | 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. | Number of cases analyzed for select cognitive tests differs from overall number analyzed due to missing data. | Posted | Mean | Standard Error | ml/min/100g | baseline and 12 weeks |
|
|
|
| Secondary | Aortic Stiffness at Baseline and 12 Weeks | Carotid-femoral pulse wave velocity (CFPWV) | Number of cases analyzed for select cognitive tests differs from overall number analyzed due to missing data. | Posted | Mean | Standard Error | m/sec | baseline and 12 weeks |
|
|
|
| Secondary | Blood Pressure at Baseline and 12 Weeks | Seated systolic and diastolic blood pressure assessed using automated oscillometric sphygmomanometer. | Posted | Mean | Standard Error | mmHg | baseline and 12 weeks |
|
|
|
| Other Pre-specified | Neurovascular Coupling at Baseline and 12 Weeks | Cerebrovascular reactivity to cognitive tasks | Not Posted | baseline and 12 weeks | Participants |
| Other Pre-specified | Functional Brain Connectivity at Baseline and 12 Weeks | functional brain connectivity assessed by MRI | Not Posted | baseline and 12 weeks | Participants |
| Other Pre-specified | Neuronal Activation at Baseline and 12 Weeks | Functional MRI (fMRI) to cognitive task | Not Posted | baseline and 12 weeks | Participants |
| Other Pre-specified | Brain Volume at Baseline and 12 Weeks | White and grey matter volume assessed by structural MRI | Not Posted | baseline and 12 weeks | Participants |
| 25 |
| 0 |
| 25 |
| 12 |
| 25 |
| EG001 | Nicotinamide Riboside | Niagen® (ChromaDex, Inc.) 500 mg, twice daily Niagen®: 250 mg capsules (4 capsules daily) | 0 | 24 | 0 | 24 | 8 | 24 |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment | Sleep disturbance |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Heart palpitations | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment | panic attack |
|
| Triglycerides increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ε2/ε4 |
|
| ε3/ε3 |
|
| ε3/ε4 |
|
| ε4/ε4 |
|
| Week 12 |
|
|
| Week 12 |
|
|
| Diastolic (Baseline) |
|
| Diastolic (Week 12) |
|