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Not 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

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 eventsTreatment 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

Org study ID2025p002197
NCT IDNCT07278492

Timeline

Milestones

Study first posted2025-12-12actual
Last update posted2026-06-25actual
Study start2026-07-31estimated
Primary completion2028-03-31estimated
Study completion2028-06-30estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
11
Safety / tolerability / PK
3
Other clinical outcomes
2
Neuroimaging
1

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Pharmacodynamics - steady state concentration of NAD+ in the brain

Time frame:Baseline and Day 28

concentration, descriptive

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Treatment emergent adverse events

Time frame:Baseline to 56 days after drug administration

event count, event

Primary/protocol endpoint

Treatment emergent serious adverse events

Time frame:Baseline to 56 days after drug administration

event count, event

Secondary/protocol endpoint

Pharmacokinetics of NMN

Time frame:Baseline to 56 days

descriptive

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:Baseline to Day 56

change from baseline, improvement

Other/protocol endpoint

Physical Function

Time frame:Baseline to Day 28

descriptive

Other (unclassified)

11 endpoints
Secondary/protocol endpoint/low confidence

Pharmacodynamics - Blood NAD+ level

Time frame:Baseline to Day 56

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamics - Plasma concentrations of NAD+ metabolites

Time frame:Pre-dose up to Day 28

concentration, descriptive

Secondary/protocol endpoint/low confidence

Urine concentration of NAD+

Time frame:Day 1 and Day 28

concentration, descriptive

Secondary/protocol endpoint/low confidence

Hemoglobin A1c (HbA1c)

Time frame:Change from baseline to 28 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Fasting glucose and insulin

Time frame:Baseline to 28 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Time frame:Change from baseline to 28 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in biomarkers of aging: Insulin Growth Factor 1 (IGF-1)

Time frame:Baseline to 28 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in biomarkers of aging: Triiodothyronine (T3)

Time frame:Baseline to 28 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in biomarkers of aging: Tumor necrosis factor-alpha (TNF-alpha)

Time frame:Baseline to 28 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in biomarkers of aging: F2-isoprostanes (F2-IsoPs)

Time frame:Baseline to 28 days

change from baseline, improvement

Other/protocol endpoint/low confidence

Muscle strength and endurance

Time frame:Baseline to Day 28

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.