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Taking people in NorwayPhase 2

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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