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ACTIVE NOT RECRUITING
NCT05040321
PHASE1/PHASE2

Sirtuin-NAD Activator in Alzheimer's Disease

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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