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Trial · Interventional

RecruitingPhase 2Registry data

Comparisons of NAD Precursors for Neuroenhancement in Glaucoma Patients

NCTNCT06991712 (opens ClinicalTrials.gov in a new tab)Other idH029
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
138 participants (estimated)
Sponsor
Christopher Kai Shun Leung · Other
Design
Randomized · Quadruple masking
Countries
1 country

Hong Kong

Start
19 May 2025
Primary completion
31 Dec 2025 (estimated)
Completion
31 Dec 2026 (estimated)
First posted
28 May 2025
Last update posted
26 Jun 2025
Conditions
Glaucoma

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

    Comparisons of NAD Precursors for Neuroenhancement in Glaucoma Patients

    NCT06991712

    19 May 2025 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this clinical trial is to determine whether oral supplementation with different nicotinamide adenine dinucleotide (NAD) precursors can improve visual function in adults with primary open-angle glaucoma. The main questions it aims to answer are: 1. Does daily oral administration of equimolar doses of nicotinamide riboside (NR), nicotinamide (NAM), nicotinamide mononucleotide (NMN), or nicotinic acid (NA) improve visual field sensitivity in glaucoma patients over the short term? 2. How do plasma NAD+ metabolite profiles change after administration of each precursor, and do these changes relate to improvements in visual function? Researchers will compare NR, NAM, NMN, NA, and placebo groups to see if any of the NAD precursors lead to greater improvements in visual field sensitivity or changes in blood NAD+ metabolite levels compared to placebo. Participants will: Be randomly assigned to receive one of the four NAD precursors or placebo daily for two weeks. Undergo comprehensive eye examinations, including visual field testing and optical coherence tomography, at baseline and after two weeks. Provide blood samples before and after the intervention for measurement of NAD+ metabolites. Have safety monitored through clinical examination. This study will help identify whether boosting NAD+ levels with specific precursors offers functional benefit in glaucoma, and which blood metabolites may mediate these effects.

Interventions

  • Nicotinamide RibosideDietary supplement
  • NicotinamideDietary supplement
  • Nicotinamide MononucleotideDietary supplement
  • Nicotinic AcidDietary supplement
  • Placebo (Corn Starch)Other
  • Placebo (Corn Starch)Other

Arms6

  • Experimental

    Nicotinamide Riboside (Phase I)

  • Active comparator

    Nicotinamide (Phase I)

  • Active comparator

    Nicotinamide Mononucleotide (Phase II)

  • Active comparator

    Nicotinic Acid (Phase II)

  • Placebo comparator

    Placebo (Phase I)

  • Placebo comparator

    Placebo (Phase II)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in visual field sensitivity

    Time frame · 2 weeks

    Registry description

    Visual field will be measured with automated static perimetry by the Humphrey Field Analyzer 3 24-2 SITA standard strategy (HFA; Carl Zeiss Meditec). Two reliable visual fields will be obtained for each eye at the baseline examination, with at least 10 minutes of rest in between, and two reliable visual fields will be obtained for each eye at week two. Change in visual field index (VFI) and threshold sensitivity (dB) before and two weeks after intervention between treatment groups will be compared.

Secondary outcomes(3)

  1. Blood NA and NAD+ metabolome

    Time frame · 2 weeks

    Registry description

    At baseline, plasma and PBMC samples will be collected on the day of VF test before the intake of NAD precursor or placebo between 9am and 10am. After two weeks of oral administration of NAD+ precursor or placebo, two blood samples will be collected: between 9 am and 10 am (pre-dose), and then between 11am and 12 noon (post-dose). The sample will be processed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and chromatography-tandem mass spectrometry (GC-MS/MS) to measure the amounts of NAD+ metabolites. Changes in NAD metabolites before and 2 weeks after intake of NAD precursors will be compared between treatment groups.

  2. Change in pattern ERG measurements

    Time frame · 2 weeks

    Registry description

    Pattern Electroretinogram (PERG) will also be performed at baseline and follow-up for every other subject included in the study. Changes in PERG measurements including P50 and N95 amplitudes, before and two weeks after intervention, will be compared between the placebo group and the NAD precursor group.

  3. Retinal nerve fiber layer thickness and defect imaging by optical coherence tomography

    Time frame · 2 weeks

    Registry description

    At baseline and week two follow-up visits, RNFL imaging will be performed with the Cirrus HD-OCT (Carl Zeiss Meditec) using the optic nerve head (6x6 mm2) cube scan covering both the macula and the parapapillary area (512x256 pixels). Changes in average RNFL thickness before and two weeks after intervention will be compared between treatment groups.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2022

6 results

Oral Administration of Nicotinamide Mononucleotide Is Safe and Efficiently Increases Blood Nicotinamide Adenine Dinucleotide Levels in Healthy Subjects.

Okabe et al. 2022Frontiers in nutritioncited by 86

PMID 35479740PMC9036060DOI 10.3389/fnut.2022.868640PUB-35479740

CC BY6 results
Download PDFSee results (6)

Indexing hint: Animal study · 2021

12 results

Safety evaluation after acute and sub-chronic oral administration of high purity nicotinamide mononucleotide (NMN-C®) in Sprague-Dawley rats.

Cros et al. 2021Food and chemical toxicology : an international journal published for the British Industrial Biological Research Associationcited by 17

PMID 33587977DOI 10.1016/j.fct.2021.112060PUB-33587977

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * glaucoma patients * age ≥ 18 years * best corrected VA ≥20/40 * IOP \<21 mmHg * visual field mean deviation better than -24 dB on standard automated perimetry 24-2 SITA standard Exclusion Criteria: * pathological myopia * diseases that may cause visual field loss or optic disc abnormalities other than glaucoma * inability to perform reliable visual field * suboptimal quality of OCT images * diabetic retinopathy/maculopathy * history of abnormal liver function within 12 months * known allergy to NAD precursor supplement(s) * pregnancy or lactation * use of NAD precursor supplements 14 days prior to baseline.

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