Actively Recruiting
The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared With Placebo in Huntington's Disease
Led by Oslo University Hospital · Updated on 2025-03-19
120
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared With Placebo in Huntington's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed Huntington's disease gene expansion with 36 or more CAG repeats
- Clinically manifest Huntington's disease with clear neurological signs
- Early or mid-stage disease at Shoulson-Fahn stage 1-3 and Total Functional Capacity greater than 2
- Ability to walk indoors unassisted or with walking aids
- Ability to write, complete pen-and-paper tests, and answer questionnaires
- Ability to attend study visits independently or with assistance
- Ability to tolerate blood draws
- Women of childbearing potential must use highly effective birth control during the study
- Able to provide signed informed consent
You will not qualify if you...
- Other significant neurological or psychiatric disorders
- Suicide attempt or active suicidal thoughts within 12 months before screening
- Alcohol or substance dependence or abuse within 12 months prior to baseline visit
- Any cancer within 5 years before screening except certain skin or cervical cancers
- Established coronary artery disease or significant cerebrovascular disease
- High age-specific cardiovascular risk by NORRISK2 criteria
- Any medical condition that may affect safety, compliance, or study results
- Use of vitamin B3 supplements within 3 months before screening
- Planned major surgery during study that could affect clinical ratings
- Electroconvulsive therapy
- Use of therapies with severe side effects that may affect safety or compliance
- Previous gene therapy for Huntington's disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0372
Actively Recruiting
Research Team
E
Ellen H Maurtveten, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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