NCT07278492Not yet recruitingPhase 1
NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome
Nicotinamide Adenine Dinucleotide Augmentation to Prevent or Reverse the Progression of Alzheimer's Disease in People With Down Syndrome
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 31 Aug 2026
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT07278492
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 31 Aug 2026 to the primary completion date, 29 Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current alcohol or substance use disorder or dependence (DSM 5 criteria).
- Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
- An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
- Has a history of anaphylaxis from vitamin B3 derivatives
Lab values
- Fasting morning UACR \> 5,000 mg/ g creatinine
- Other laboratory abnormalities:
- Has AST or ALT \> 3 times the upper limit of normal
- eGFR \< 30 mL/ min / 1.73 m2
- Hematocrit \< 0.34 or \> 0.50 L/L
Other
- A major adverse cardiovascular event in preceding 3 months
- Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
- BMI \> 42.5 kg/ m2
- Non-ambulatory
Who the study is looking for
- A diagnosis of full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21, confirmed by karyotype analysis or clinical documentation.
- 18 years or older
- Participant has a caregiver/ informant who has direct contact with the participant \>10 hours/ week and who can provide information about participant's health
- Participant or Legal Authorized Representative is able to understand and willing to provide written informed consent and capable of completing study assessments.
- In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.