NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07278492
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Down Syndrome (DS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MIB-626 — DRUG
    MIB-626 tablets will be provided at dose strength of 500mg. Three doses will be studied in ascending order: 500 mg (one tablet) once daily; 1000 mg (two 500 mg tablets once daily) or 1000 mg (two 500 mg tablets) twice daily.
  • Placebo — DRUG
    Matching placebo tablets (number and frequency of tablets will match the active intervention group at each of the three doses)

Study Details

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).

Key Dates

Start date
Apr 1, 2026
Status verified
Dec 2025
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Safety and pharmacokinetic ascending dose intervention group
    MIB-626 tablets will be provided at dose strength of 500mg. Three doses will be studied in ascending order: 500 mg (one tablet) once daily; 1000 mg (two 500 mg tablets once daily) or 1000 mg (two 500 mg tablets) twice daily.
  • Placebo Comparator: Placebo tablets
    Matching placebo tablets (number and frequency of tablets will match the active intervention group at each of the three doses)

Primary Outcome Measure

Treatment emergent adverse events [ Time Frame: Baseline to 56 days after drug administration ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Nancy Latham, PhD
[email protected]
6179999195
Shalender Bhasin, MB, BS (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Brian Skotko, MD, MPP
[email protected]
617-643-8912

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By research site
Brigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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