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NCT05040321 · ClinicalTrials.gov registry record · Phase 1
Sirtuin-NAD Activator in Alzheimer's Disease
A Phase 1 study of Dementia and Alzheimer's Disease (Incl Subtypes), sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05040321 is a Phase 1 study of Dementia and Alzheimer's Disease (Incl Subtypes) that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 22 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05040321, a Phase 1 study of Dementia and Alzheimer's Disease (Incl Subtypes), is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MIB-626
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05040321
The ClinicalTrials.gov registry entry for NCT05040321 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05040321 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05040321 about?
NCT05040321 is a clinical study titled "Sirtuin-NAD Activator in Alzheimer's Disease". 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 ...
What is the current status of trial NCT05040321?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-12-01. Estimated completion is 2026-04-30.
What conditions does trial NCT05040321 study?
This clinical trial studies the following conditions: Dementia, Alzheimer's Disease (Incl Subtypes).
What interventions are being tested in trial NCT05040321?
The interventions under investigation include: Placebo (DRUG), MIB-626 (DRUG).
Who is sponsoring clinical trial NCT05040321?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05040321 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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