Tests a vitamin B3 supplement in people with Huntington's disease
Tests nicotinamide riboside, a vitamin B3 form, in adults with Huntington's disease.
Key facts
- Who runs it
- Oslo University Hospital
- Where
- Oslo, NorwaySee the site
- Trial code
- Registry title
- The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared With Placebo in Huntington's Disease
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 120 people, planned
- Started
- 18 Mar 2025
- Expected to end
- Mar 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Nicotinamide Riboside (NR)
- Placebo
- Record updated
- 19 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with early or mid-stage Huntington's disease who carry the HD gene change. It tests nicotinamide riboside (a form of vitamin B3) against placebo for 2 years.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Early or mid-stage Huntington's disease (Shoulson-Fahn stage 1-3, Total Functional Capacity above 2), with clear neurological signs.
- Earlier treatment
- No vitamin B3 supplements within 3 months before screening or during the study. No past gene therapy for Huntington's disease. No electroconvulsive therapy.
- Biomarker or test result
- A genetic test confirming 36 or more CAG repeats in the HTT gene.
Main reasons for not taking part
- Other serious neurological or psychiatric disorders, as judged by the investigator
- Suicide attempt or active suicidal thoughts within 12 months before screening
- Alcohol or substance dependence or abuse within 12 months before the baseline visit
- Cancer within 5 years before screening (some skin and cervical cancers excepted)
- Coronary artery disease, serious brain blood vessel disease, or high cardiovascular risk
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- Confirmed HD gene expansion carrier status with a diagnostic genetic test confirming ≥36 CAG-repeats in HTT
- Clinically manifest HD with objective neurological signs corresponding to Diagnostic Confidence Level 4 based on the Total Motor Score of the UHDRS
- Early or mid-stage disease corresponding to Shoulson-Fahn stage 1-340 and Total Functional Capacity (TFC) > 2
- Ability to walk indoors unassisted or by the help of walking aids only as determined at screening and baseline visits
- Ability to write and perform pen-and-paper tests (SDMT, SWRT, MoCA) and complete questionnaires (HADS-SIS, SF-12) included in the study protocol
- Ability to follow up telephone appointments and reliably attend study visits independently or with the assistance of a reliable partner (family member, friend, or assistant)
- Ability to tolerate blood draws
- Participants who are women of childbearing potential should use an approved method for highly effective birth control throughout the study intervention period
- Capable of giving signed informed consent
Who cannot take part
- Attempted suicide or active suicidal ideation within 12 months prior to screening
- A history of alcohol or substance use within a 12 month period prior to the baseline visit, fulfilling criteria of dependence or abuse under the International Classification of Diseases (ICD-10) F10-F19 (not including tobacco dependence)
- Any malignancy within 5 years prior to screening (except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated) or history of a previously treated malignant disorder > 5 years prior to screening with a remaining clinically significant recurrence risk
- Use of vitamin B3 supplements in any form or dose during the study or within 3 months prior to screening
- Planned major surgery of any kind during the study period that is likely to affect clinical ratings, including, but not limited to, joint replacement and spinal surgery
- Electroconvulsive therapy
- Any medical therapy with known severe side effects that, in the investigator's judgement, may preclude the subject's safe participation in the study, interfere with the ability to comply with study procedures or confound the interpretation of study results
- Presence of other co-morbid neurological or psychiatric disorders considered clinically significant by the investigator, including, but not limited to psychotic disorders, brain tumor or inflammatory neurological disease
- Established coronary artery disease or clinically significant cerebrovascular disease as deemed by the investigator
- Any medical condition which, in the investigator's judgement, may preclude the subject's safe participation in the study, interfere with the ability to comply with study procedures or confound the interpretation of study results
- Any history of gene therapy exposure for the treatment of HD
- High age-specific cardiovascular risk as defined by the NORRISK2 algorithm based on smoking status, systolic blood pressure, serum total cholesterol and family history, modeled on the Norwegian population
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Norway
- Oslo University HospitalOslo, NorwayContact: Lasse Pihlstrøm, PhDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 2 groups in the trial
- Nicotinamide ribosideTreatment being tested
Nicotinamide riboside, 2 capsules of 500mg twice daily
Treatment: Nicotinamide Riboside (NR)
- PlaceboPlacebo, for comparison
Nicotinamide riboside, 2 capsules twice daily
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The NAD-HD Study: A Parallel-group, Phase 2, Double-blind Study to Investigate the Efficacy and Safety of Oral Nicotinamide Riboside Compared With Placebo in Participants Aged 18 to 80 Years With Huntington's Disease
- Plain-language title
- Tests a vitamin B3 supplement in people with Huntington's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06853743, who can take part
- Record updated
- 19 March 2025