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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07278492
The ClinicalTrials.gov registry entry for NCT07278492 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07278492 reports 0 study locations.
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.
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