NCT06054529

Brief Summary

To learn how altered metabolism in GBM causes tumor growth and resistance to drug therapy. In this pilot research study, we will dose GBM patients with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

September 11, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

September 20, 2023

Last Update Submit

March 12, 2025

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Subtyping of GBM tumors as Classical, Proneural or MES (based on RNA-seq)

    Resected tumor tissue will undergo routine testing

    2 months

Study Arms (1)

Participants in surgery

Surgical removal of the GBM tumor.

Procedure: Surgical removal of the GBM tumorOther: d4-NAM infusion

Interventions

Surgical removal of the GBM tumorPROCEDURE

Surgical removal of the GBM tumor

Participants in surgery
d4-NAM infusionOTHER

Following the surgical removal of the GBM tumor, GBM patients will be dosed with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness.

Also known as: Nicotinamide
Participants in surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The research being pursued in this study is relevant to all GBM patients including these who are cognitively impaired.

You may qualify if:

  • Preoperative MRI consistent with a primary intracranial malignant brain tumor.
  • Must be 18 years of age or older.
  • Patient eligible for debulking surgery/resection.

You may not qualify if:

  • Inability to obtain pre-operative IV access.
  • Use of Tru Niagen, Basis (or any other nicotinamide riboside (NR)-containing NAD+ booster) or niacin supplements within one month prior to Study Visit 1.
  • Participation in studies involving investigational drug(s) within 30 days prior to Study Visit 1
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Study Visit 1 (participants may not donate blood any time during the study, through the final study day)
  • Presence of any condition that, in the opinion of Dr. Field, compromises participant safety or data integrity or the participant's ability to complete study days.
  • Pregnancy, lactation or \< 9 months postpartum from the Study Visit 1 date.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Adeline Divoux, PhD

    AdventHealth Translational Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 26, 2023

Study Start

September 11, 2023

Primary Completion

January 22, 2024

Study Completion

December 1, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

US(1)