The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared With Placebo in Huntington's Disease

Sponsor
Oslo University Hospital
Study ID
NCT06853743
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicotinamide Riboside (NR) — DIETARY_SUPPLEMENT
    Nicotinamide riboside, 2 capsules of 500mg taken twice daily for 2 years
  • Placebo — DIETARY_SUPPLEMENT
    Placebo, 2 capsules twice daily for 2 years

Study Details

The goal of this clinical trial is to learn if oral supplement of nicotinamide riboside (NR), a form of vitamin B3, slows disease progression in adults with Huntington's disease. It will also learn about the safety of nicotinamide riboside. The main questions it aims to answer are: * Does NR slow progression of overall symptom burden in Huntington's disease? * Does NR have an effect on any specific symptom domain in Huntington's disease? * Does supplementation with NR cause side-effects or safety issues when used for 2 years in Huntington's disease? * Does NR have an effect on selected blood, imaging, and oculomotor biomarkers in Huntington's disease? Researchers will compare NR to a placebo (a look-alike substance that contains no active compound) to see if NR works to treat Huntington's disease. Participants will: * Take 2000mg NR or a placebo every day for 2 years * Visit the clinic once every 6 months for clinical investigations and tests * Undergo brain imaging at baseline and upon completion of the study period

Key Dates

Start date
Mar 18, 2025
Status verified
Mar 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nicotinamide riboside
    Nicotinamide riboside, 2 capsules of 500mg twice daily
  • Placebo Comparator: Placebo
    Nicotinamide riboside, 2 capsules twice daily

Primary Outcome Measure

Change from Baseline in the composite Unified Huntington's Disease Rating Scale at 730 days [ Time Frame: From baseline to the end of treatment at 730 days (2 years) ]

Central Contacts

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