NCT06579209

Brief Summary

The goal of this clinical trial is to learn whether Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women aged 40-80. The main questions it aims to answer are: Will cognitive functioning change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving NAD+ to those receiving placebo to see if the results differ. Participants will: Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

August 28, 2024

Last Update Submit

March 10, 2026

Conditions

Cognitive ChangeInflammationNeurodegenerative Diseases

Outcome Measures

Primary Outcomes (3)

  • Neurocognition

    NIH Toolkit Cognition Battery, Automated Neuropsychological Assessment Metrics

    four weeks

  • Neurodegenerative disease panel

    BDNF, Cathespin D, MPO, PAI-1 (total), PDGF-AA, PDGF-AB/BB, RANTES, slCAM-1, sNCAM, sVCAM-1

    four weeks

  • Markers of systemic inflammation

    GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A, IL-23, TNFα

    four weeks

Study Arms (3)

Pre-testing prior to intervention

NO INTERVENTION

Prior to receiving the supplement, either Nicotinamide adenine dinucleotide or the placebo, participants will undergo cognitive testing and a blood draw.

Post-testing after intervention

NO INTERVENTION

After receiving the supplement, either Nicotinamide adenine dinucleotide or the placebo, participants will undergo cognitive testing and a blood draw.

Intervention

EXPERIMENTAL

For four weeks, the participant will consume an oral supplement, either Nicotinamide adenine dinucleotide or a placebo.

Dietary Supplement: TreatmentOther: Placebo

Interventions

TreatmentDIETARY_SUPPLEMENT

Participants will take a supplement for four weeks. The supplement will either be Nicotinamide adenine dinucleotide or a placebo.

Also known as: Nicotinamide adenine dinucleotide
Intervention
PlaceboOTHER

Participants will take a supplement for four weeks. The supplement will either be Nicotinamide adenine dinucleotide or a placebo pill.

Intervention

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-reported biological sex
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as Female
  • Have a BMI of 18.5 or above
  • Must be able to swallow tablets

You may not qualify if:

  • Those who are pregnant, breastfeeding, or taking hormone medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Independence Square, University of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

InflammationNeurodegenerative Diseases

Interventions

TherapeuticsNAD

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNervous System Diseases

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

December 1, 2024

Primary Completion

February 20, 2026

Study Completion

February 20, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)