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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
Lead sponsor
Asset
MIB-626
Listed sites
2
Recruiting sites
-
Enrollment
24
estimated
Study population
Alzheimer’s disease
Key I/E criterion
•Study partner/caregiver required
Primary endpoints
•Treatment emergent adverse events•Treatment emergent serious adverse events
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (17)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Neuroimaging
1 endpointPharmacodynamics - steady state concentration of NAD+ in the brain
Time frame:Baseline and Day 28
concentration, descriptive
Safety / tolerability / PK
3 endpointsTreatment emergent adverse events
Time frame:Baseline to 56 days after drug administration
event count, event
Treatment emergent serious adverse events
Time frame:Baseline to 56 days after drug administration
event count, event
Pharmacokinetics of NMN
Time frame:Baseline to 56 days
descriptive
Other clinical outcomes
2 endpointsBlood pressure
Time frame:Baseline to Day 56
change from baseline, improvement
Physical Function
Time frame:Baseline to Day 28
descriptive
Other (unclassified)
11 endpointsPharmacodynamics - Blood NAD+ level
Time frame:Baseline to Day 56
descriptive
Pharmacodynamics - Plasma concentrations of NAD+ metabolites
Time frame:Pre-dose up to Day 28
concentration, descriptive
Urine concentration of NAD+
Time frame:Day 1 and Day 28
concentration, descriptive
Hemoglobin A1c (HbA1c)
Time frame:Change from baseline to 28 days
change from baseline, improvement
Fasting glucose and insulin
Time frame:Baseline to 28 days
change from baseline, improvement
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame:Change from baseline to 28 days
change from baseline, improvement
Change in biomarkers of aging: Insulin Growth Factor 1 (IGF-1)
Time frame:Baseline to 28 days
change from baseline, improvement
Change in biomarkers of aging: Triiodothyronine (T3)
Time frame:Baseline to 28 days
change from baseline, improvement
Change in biomarkers of aging: Tumor necrosis factor-alpha (TNF-alpha)
Time frame:Baseline to 28 days
change from baseline, improvement
Change in biomarkers of aging: F2-isoprostanes (F2-IsoPs)
Time frame:Baseline to 28 days
change from baseline, improvement
Muscle strength and endurance
Time frame:Baseline to Day 28
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.