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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: Active Phase 1 study of Dementia and Alzheimer's Disease (Incl Subtypes), sponsored by Brigham and Women's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
change in CSF concentrations of MIB-626 at baseline and on day 90 at steady state
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 |
What the registry record for NCT05040321 still lists
NCT05040321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05040321's enrollment target sits among peer trials
22 178th of 199 higher than 22 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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