Could a Vitamin-Like pill protect the brains of people with down syndrome?

NCT ID NCT07278492

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This early-stage trial tests a supplement called MIB-626 (a form of NMN) in 24 adults with Down syndrome. The goal is to see if it is safe and can raise NAD+ levels, which may help protect against Alzheimer's disease. Participants take the pill or a placebo for 28 days and are monitored for side effects and changes in brain chemistry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: MIB-626 (a form of nicotinamide mononucleotide, or NMN)
What this could lead to: If safe and well-tolerated, this could point toward a way to slow or prevent Alzheimer's disease in people with Down syndrome.
What could go wrong: This is a very early, small Phase 1 trial focused on safety, not effectiveness. It may not show any benefit, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A diagnosis of full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21, confirmed by karyotype analysis or clinical documentation. 2. 18 years or older 3. Participant has a caregiver/ informant who has direct contact with the participant \>10 hours/ week and who can provide information about participant's health 4. Participant or Legal Authorized Representative is able to understand and willing to provide written informed consent and capable of completing study assessments. 5. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months. Exclusion Criteria 1. Fasting morning UACR \> 5,000 mg/ g creatinine 2. Other laboratory abnormalities: 1. Has AST or ALT \> 3 times the upper limit of normal 2. eGFR \< 30 mL/ min / 1.73 m2 3. Hematocrit \< 0.34 or \> 0.50 L/L 3. A major adverse cardiovascular event in preceding 3 months 4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter 5. Current alcohol or substance use disorder or dependence (DSM 5 criteria). 6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures. 7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month. 8. Has a history of anaphylaxis from vitamin B3 derivatives 9. BMI \> 42.5 kg/ m2 10. Non-ambulatory

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Conditions

The condition(s) this trial relates to.

Down syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Down syndrome (DS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a Vitamin-Like pill protect the brains of people with down syndrome?

What the study statuses mean