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Sirtuin-NAD Activator in Alzheimer's Disease
Sponsor: Brigham and Women's Hospital
Summary
The primary objectives are to: 1. To determine whether MIB-626, after its daily oral administration, penetrates the blood-brain barrier in humans by measuring the cerebrospinal fluid (CSF) concentrations of MIB-626 and its key metabolites, nicotinamide (NAM), NR, 2-PY, and MeNAM at baseline and on day 90 at steady state. 2. To evaluate whether oral MIB-626 administration engages the sirtuin-NAD pathway by determining the abundance of NAD (a SIRT1 substrate) in the brain using ultra-high field 7T magnetic resonance spectroscopy and in peripheral blood mononuclear cells using a validated LC-MS/MS assay. 3. To determine whether MIB-626 alters the circulating biomarkers of aging that the geroscience experts have recommended (HbA1C, IGF1, T3, IL6, TNF, and urinary F2-isoprostane).
Official title: A Proof of Concept Trial of a Sirtuin-NAD Activator in Alzheimer's Disease
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2021-12-01
Completion Date
2026-04-30
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
MIB-626
Participants will be randomized to either receive MIB-626 or matching placebo. The proposed intervention - targets multiple contributors to the pathology of AD; MIB-626 improves mitochondrial function, bioenergetics, and insulin sensitivity, inhibits A beta accumulation by reducing its synthesis and increasing its clearance, reduces neuroinflammation, exerts neuronal protective effects, and promotes neuronal regeneration and connectivity in preclinical models.
Placebo
Subjects will be randomized to receive either the placebo or 1000 mg MIB-626 twice daily orally.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States