Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide riboside (NR) | Drug | Participants will take their weight-based dose of NR once daily by mouth with food for 60 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood | Baseline , 8 weeks | |
| Change in cerebral oxygenation and perfusion as assessed by the Head-up tilt table testing (HUTT) with near-infrared spectroscopy (NIRS) monitoring. | Baseline , 8 weeks | |
| Change in cognitive function as assessed by the NIH Toolbox assessment | NIH Toolbox assessment evaluates multiple domains of cognitive performance including executive function, attention, episodic memory, language, processing speed, and working memory. Individual test scores are combined into a composite cognition score and reported as age-adjusted T-scores (mean = 50, SD = 10), where higher scores indicate better cognitive function. | Baseline , 8 weeks |
| Change in autonomic symptoms as assessed by the Composite Autonomic Symptom Score 31 (COMPASS-31) survey | This is a 31 item questionnaire and each is scored from 0 (no symptoms) to 100(maximum symptom burden), with higher scores indicating more severe autonomic dysfunction. | Baseline , 8 weeks |
| Change in Impact of headaches as assessed by the Headache Impact Test (HIT-6) questionnaire | HIT-6 questionnaire consists of 6 questions, each scored from 6(never) to 13(always), with total scores ranging from 36 to 78. Higher scores indicate a greater impact of headaches on quality of life. | Baseline, 8 weeks |
| Pulmonary function tests (PFTs), including spirometry and lung volume measurements | Baseline, 8 weeks | |
| Change in Aortic diameter as assessed by the echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Nicotinamide adenine dinucleotide (NAD+) in whole blood as measured by high-performance liquid chromatography (HPLC) | Baseline , 8 weeks | |
| Change in Levels of NR in whole blood as measured by high-performance liquid chromatography (HPLC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianna M Milewicz, MD, PhD | Contact | (713) 500-6725 | Dianna.M.Milewicz@uth.tmc.edu | |
| David R Murdock, MD | Contact | (713) 500-6735 | David.R.Murdock@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dianna Milewicz, MD, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline , 8 weeks |
| Baseline , 8 weeks |
| Safety as assessed by number of participants that show drug toxicity as shown in bloodwork | Baseline |
| Safety as assessed by number of participants that show drug toxicity as shown in bloodwork | end of study (8 weeks after baseline) |
| Tolerability as assessed by the number of patients who complete study | end of study( 8 weeks after baseline) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D001018 | Aortic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
Not provided
Not provided
Not provided