Active — Not RecruitingPhase 1/2

Sirtuin-NAD Activator in Alzheimer's Disease

United States22 participantsStarted 2021-12-01

Plain-language 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).

Who can participate

Age range55 Years – 85 Years

SexALL

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Inclusion criteria

✓. A man or a woman between the ages of 55 and 85 years (inclusive)
✓. Meets National Institute on Aging-Alzheimer's Association (NIA-AA) clinical diagnostic criteria for AD dementia
✓. Has evidence of AD pathological process by a positive amyloid assessment with cerebrospinal fluid (CSF) Aβ42
✓. Has a Clinical Dementia Rating (CDR) global score of 0.5 or 1
✓. Has a Mini-Mental State Exam (MMSE) Score of 18 to 26 (inclusive)
✓. Has a 15-item Geriatric Depression Scale (GDS) score of \< 6
✓. Impaired memory performance below education adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall (LM-IIa) of the Wechsler Memory Scale-Revised (WMS-R) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2)
✓. May take Food and Drug Administration (FDA) approved medications for the treatment of AD dementia (cholinesterase inhibitors and/or memantine), but if taking such medications, they must be stable for at least 8 weeks before screening

Exclusion criteria

What they're measuring

change in CSF concentrations of MIB-626

Timeframe: 90 days

Trial details

NCT IDNCT05040321

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

View on ClinicalTrials.gov More Alzheimer's Disease (Incl Subtypes) trials