Frankly Ohio Understands New Truths Always In News Ohio Finds Youth Over Under Tomorrow
CLINICAL TRIAL PROTOCOL
KALKI BOMMARAJU MD MPH
PERSIMMONS MEDICAL/IV-MEDICAL.COM
PHILIP F BINKLEY MD MPH
Title
Prospective, Open-Label, Longitudinal Cohort Study Evaluating the Clinical, Functional, and Biomarker Effects of Intravenous NAD⁺ Infusion With Continuous Digital Monitoring Over 20 Years i.e. FOUNTAINOFYOUTH CLINICAL TRIAL
Frankly Ohio Understands New Truths Always In News Ohio Finds Youth Over Under Tomorrow
Frankly Ohio Understands New Truths Always In News Ohio Finds Youth Over Under Tomorrow
Study Design
Prospective, open-label, non-randomized cohort study with no blinding. Both the patient and the physician know the patient is receiving NAD⁺ infusion therapy. Patients are followed for 20 years with structured assessments every 6 months and continuous digital monitoring.
Objectives
Primary Objective
To evaluate whether long-term NAD⁺ infusion therapy is associated with disease progression, disease regression, hospitalization rates, and survival across a broad real-world patient population.
Secondary Objectives
To evaluate changes in functional status, quality of life, physiologic aging markers, video-based appearance and movement over time, continuously collected home vital sign data, laboratory trends, and disease-specific biomarkers including BNP in CHF patients.
Population
Inclusion Criteria
Adults age 18 years or older
Willing to receive NAD⁺ infusions
Willing to participate in longitudinal follow-up
Willing to allow clinical data, video data, home monitoring data, and laboratory data to be stored in the study database and analyzed by AI
Exclusion Criteria
None
Patients with all levels of illness severity may be enrolled, including stage IV cancer, congestive heart failure, neurodegenerative disease, advanced frailty, and multiple chronic medical conditions.
Intervention
Patients receive intravenous NAD⁺ infusion according to the treating physician’s clinical protocol. Dose, frequency, infusion duration, and treatment changes are documented in the medical record and study database.
Specialty-Directed NAD⁺ Infusion Determination
For all enrolled patients, NAD⁺ infusion parameters including dose, volume, rate, and frequency are determined based on the patient’s underlying medical conditions, with oversight by the appropriate physician as outlined below.
Oncology
For patients with active or prior malignancy, NAD⁺ infusion parameters are determined by an oncologist.
Hematology
For patients with hematologic conditions, NAD⁺ infusion parameters are determined by a hematologist.
Neurology
For patients with neurologic conditions, NAD⁺ infusion parameters are determined by a neurologist.
Pulmonary Medicine
For patients with pulmonary conditions, NAD⁺ infusion parameters are determined by an internal medicine physician or hospitalist.
Critical Care
For patients with critical illness or conditions requiring intensive monitoring, NAD⁺ infusion parameters are determined by an internal medicine physician or hospitalist.
Gastrointestinal Conditions
For patients with gastrointestinal disorders, NAD⁺ infusion parameters are determined by an internal medicine physician or hospitalist.
Other Internal Medicine Conditions
For all other conditions falling within internal medicine, NAD⁺ infusion parameters are determined by an internal medicine physician or hospitalist.
Non–Internal Medicine Conditions
For any medical condition outside traditional internal medicine specialties, NAD⁺ infusion parameters are determined by an internal medicine physician or hospitalist only.
Disease-Specific Treatment Modifications
Congestive Heart Failure
Patients with congestive heart failure receive reduced-volume or slower-rate NAD⁺ infusions based on tolerance. Lower volumes such as approximately 250 mL or less may be used. Infusion parameters are determined and adjusted by a cardiologist. Clinical decision-making may consider volume status, ejection fraction, symptoms, blood pressure, heart rate, recent hospitalizations, and BNP trends.
Chronic Kidney Disease and End-Stage Renal Disease
Patients with chronic kidney disease or end-stage renal disease receive individualized NAD⁺ infusion protocols. Volume, concentration, and rate are determined based on renal function, volume status, dialysis status, and electrolyte balance. Infusion parameters are determined and adjusted by a nephrologist. For patients on dialysis, infusion timing may be coordinated with dialysis sessions and adjusted to avoid fluid overload.
Follow-Up Schedule
Patients are followed for 20 years.
Every 6 Months
At each 6-month interval, the following are documented:
new diagnoses
disease progression
disease regression
hospitalizations
medication changes
changes in symptoms
functional status
quality of life
physician assessment
A video of the patient is recorded at each assessment to document facial appearance, skin appearance, posture, gait, movement, speech, and general visible aging characteristics.
Home Monitoring
Home data may include blood pressure, body weight, heart rate, home ECG monitoring, and future home laboratory testing using fingerprint or micro-blood collection technology when available. All home data are uploaded automatically into the study database when technically available.
Patients may also be provided with a home cardiac monitoring system. If a device exists with monitoring and built-in defibrillation capability suitable for outpatient use, that device may be used as part of the monitoring system.
CHF Subgroup Monitoring
Patients with congestive heart failure may undergo serial or continuous BNP monitoring to determine whether BNP predicts increased hospitalization risk. BNP levels are correlated with symptoms, hospitalizations, and clinical deterioration.
Data Collection
The following are stored in the database:
infusion records
physician notes
diagnoses
disease progression or regression assessments
laboratory values
vital signs
home monitoring data
video recordings
hospitalization data
survival data
AI Analysis
The database is continuously analyzed by AI for trend detection, disease progression patterns, disease regression patterns, aging progression or regression patterns, prediction of clinical deterioration, abnormal vital sign detection, abnormal laboratory detection, and cardiac risk detection.
If an abnormality is detected, the physician is notified.
Endpoints
Primary Endpoints
disease progression over time
disease regression over time
all-cause hospitalization
disease-specific hospitalization
all-cause mortality
Secondary Endpoints
change in blood pressure
change in weight
change in heart rate
change in laboratory markers
change in BNP in CHF patients
AI-derived risk scores
visual and functional aging trajectory over time
Safety Monitoring
Adverse events are recorded continuously. Infusion-related complications are tracked. AI-triggered alerts are reviewed by the physician. Periodic safety review is performed annually.
Study Nature
This is an open-label observational cohort study designed to follow all patients receiving NAD⁺ therapy in a real-world setting, including patients with severe and advanced disease, to determine whether measurable benefit, no effect, or harm is observed over long-term follow-up.