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NCT07278492 · ClinicalTrials.gov registry record · Phase 1
NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT07278492: Clinical Trial Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT07278492 is a Phase 1 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07278492, a Phase 1 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The aim of the study is to determine the safety and tolerability of different increasing doses of MIB-626 (a microcrystalline form of β nicotinamide mononucleotide; NMN) given daily for 28 consecutive days to adults with Down syndrome (DS). The study will also explore how the drug moves through the body over time (pharmacokinetics or PK) and how the drug affects the body in different ways (pharmacodynamics or PD). The study participants will be monitored for adverse events and measurements to detect safety events will take place including laboratory tests of blood counts, chemistries and coagulation profile, and electrocardiogram (ECG). The trial will enroll a total of 24 adults with DS who are 18 years or older and are medically stable. People enrolled in the study will be randomly assigned to receive either the active intervention (MIB-626) tablets, or placebo tablets for 28 days. Study participants will be followed for an additional 28 days (total 56 days of follow-up). This study will also explore the effect of MIB-626 on different measures associated with aging and risk of Alzheimer's Disease (AD).
Primary Outcome
All treatment emergent adverse events
Interventions
- DRUG Placebo
- DRUG MIB-626
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-07-31 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 1 |
What is known before NCT07278492 opens enrollment
NCT07278492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07278492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07278492 about?
NCT07278492 is a clinical study titled "NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome". The aim of the study is to determine the safety and tolerability of different increasing doses of MIB-626 (a microcrystalline form of β nicotinamide mononucleotide; NMN) given daily for 28 consecutive days to adults with Down syndrome (DS). The study will also explore how the drug moves through the ...
What is the current status of trial NCT07278492?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-07-31. Estimated completion is 2028-06-30.
What interventions are being tested in trial NCT07278492?
The interventions under investigation include: Placebo (DRUG), MIB-626 (DRUG).
Who is sponsoring clinical trial NCT07278492?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07278492's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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