Comparisons of NAD Precursors for Neuroenhancement in Glaucoma Patients

NCT06991712 | Recruiting Phase 2 DMC

• 1 other identifier: H029
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.How do plasma NAD+ metabolite profiles change after administration of each precursor, and do these changes relate to improvements in visual function?

Conditions

Glaucoma

Keywords

NAD Precursor; Nicotinic Acid; Nicotinamide; Nicotinamide Mononucleotide; Nicotinamide Riboside

Outcome Measures

Primary Outcomes (1)

• Change in visual field sensitivity

  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.

  2 weeks

Secondary Outcomes (3)

• Blood NA and NAD+ metabolome

  2 weeks

• Change in pattern ERG measurements

  2 weeks

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

  2 weeks

Other Outcomes (1)

• Impact of age on the change in visual field sensitivity

  2 weeks

Study Arms (6)

Nicotinamide Riboside (Phase I)

EXPERIMENTAL

Dietary Supplement: Nicotinamide Riboside

Nicotinamide (Phase I)

ACTIVE COMPARATOR

Dietary Supplement: Nicotinamide

Nicotinamide Mononucleotide (Phase II)

ACTIVE COMPARATOR

Dietary Supplement: Nicotinamide Mononucleotide

Nicotinic Acid (Phase II)

ACTIVE COMPARATOR

Dietary Supplement: Nicotinic Acid

Placebo (Phase I)

PLACEBO COMPARATOR

Other: Placebo (Corn Starch)

Placebo (Phase II)

PLACEBO COMPARATOR

Other: Placebo (Corn Starch)

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

Oral supplementation of 300mg Nicotinamide Riboside (NR) daily for 2 weeks

Also known as: NR

Nicotinamide Riboside (Phase I)

Nicotinamide DIETARY_SUPPLEMENT

Oral supplementation of 125mg Nicotinamide/Niacinamide (NAM) daily for 2 weeks

Also known as: Niacinamide, NAM

Nicotinamide (Phase I)

Nicotinamide Mononucleotide DIETARY_SUPPLEMENT

Oral supplementation of 350mg Nicotinamide Mononucleotide (NMN) daily for 2 weeks

Also known as: NMN

Nicotinamide Mononucleotide (Phase II)

Nicotinic Acid DIETARY_SUPPLEMENT

Oral supplementation of 350mg Nicotinic Acid (NA) daily for 2 weeks

Nicotinic Acid (Phase II)

Placebo (Corn Starch) OTHER

Oral supplementation of 300mg Placebo daily for 2 weeks

Placebo (Phase I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christopher Kai Shun Leung: lead

Study Sites (1)

HKU Eye Centre

Wong Chuk Hang, Hong Kong

RECRUITING

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MeSH Terms

Conditions

Glaucoma

Interventions

nicotinamide-beta-riboside; Niacinamide; Nicotinamide Mononucleotide; Niacin; Starch

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Christopher Kai-shun LEUNG, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Kai-shun LEUNG, MD

CONTACT

(852)3910-2673; cleung21@hku.hk

Nate CHAN

CONTACT

(852)3910-3906; natechan@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigators, the outcome assessors, and data analysts will be masked before and after assignment to intervention. The subject will be unmasked as per of the request of Principal Investigator in case of serious adverse event or if emergency unblinding is deemed essential for clinical management. All instances of the unblinding will be documented in the study binder. Unmasked subject will exit from the study and resumes normal clinical management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairperson and Clinical Professor

Model Details: NR, NAM, NMN, or NA in mole equivalent amount, or placebo, will be randomly assigned to 138 patients, 23 per group (a total of 4 treatment groups and 2 placebo groups). Each patient will receive a daily dose of 300 mg NR, 125 mg NAM, 350 mg NMN, 125 mg NA or 300 mg placebo (corn starch capsule) at 9 am each day for two weeks. The study will be conducted in 2 phases. In Phase I, participants will be randomized to placebo, NR, or NAM. In Phase II, participants will be randomized to receive, placebo, NA, or NMN.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 28, 2025
• Study Start: May 19, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)