Huntington DiseasePhase 2NAD-HDNCT06853743
The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared With Placebo in Huntington's Disease
A Phase 2 study testing Nicotinamide Riboside (NR) in people with Huntington Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Nicotinamide Riboside (NR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 18 Mar 2025to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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 join
- 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.
- 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.
- Established coronary artery disease or clinically significant cerebrovascular disease as deemed by the investigator.
- 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
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- 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.
- 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.
- Any history of gene therapy exposure for the treatment of HD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0372
Lasse Pihlstrøm, PhD, lasse.pihlstrom@medisin.uio.no
About this study
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
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?
Read more
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
- Huntington Disease
- Being tested
- Nicotinamide Riboside (NR), Placebo
- Keywords
- Huntington's disease, Nicotinamide riboside, Vitamin B3, NAD, Neuroprotection
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (NR)Dietary supplement
Nicotinamide riboside, 2 capsules of 500mg taken twice daily for 2 years
PlaceboDietary supplement
Placebo, 2 capsules twice daily for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide riboside | Experimental | Nicotinamide riboside, 2 capsules of 500mg twice daily Receives: Dietary Supplement: Nicotinamide Riboside (NR) |
| Placebo | Placebo comparator | Nicotinamide riboside, 2 capsules twice daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the composite Unified Huntington's Disease Rating Scale at 730 days
The cUHDRS is a composite outcome measure comprised of motor, cognitive and global functional components. It is calculated as an equally weighted sum of Z-scores, with lower scores indicating greater clincial burden of HD symptoms.
Measured: From baseline to the end of treatment at 730 days (2 years)
Secondary outcomes (4)
Number of Participants with Adverse Events
Adverse events will be defined and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) and reported for each study arm.
Measured: From baseline to the end of treatment at 730 days
Change from Baseline in the Unified Huntington's Disease Total Motor Score at 730 days
The Unified Huntington's Disease Total Motor Score is the sum of 30 items rated from 0 to 4 based on a clinical neurological assessment, where 0 is normal and 4 indicates the most severe motor deficit.
Measured: From baseline to the end of treatment ao 730 days
Change from Baseline in the Montreal Cognitive Assessment at 730 days
The Monteal Cognitive Assessment is a brief clinical test where results range from 0 to 30, and a higher score indicates better performance.
Measured: From baseline to the end of treatment at 730 days
Change from baseline in the Hospital Anxiety and Depression Scale/Snaith Irritability Scale (HADS-SIS) at 730 days
The Hospital Anxiety and Depression Scale/Snaith Irritability Scale (HADS-SIS) is a questionnaire completed by the participant with 22 questions,. Replies to each question are scored from 0 to 4, where 0 is normal and 4 is the most severe symptom
Measured: From baseline to the end of treatment at 730 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start18 Mar 2025 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, South-Eastern Norway Regional Health Authority, Klinbeforsk, The Dam Foundation, Elysium Health, NKS Olaviken Gerontopsychiatric Hospital
- Responsible party
- Principal investigator, Lasse Pihlstrøm, Oslo University Hospital
- Investigators
- Lasse Pihlstrøm, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853743
- Sponsor's protocol ID
- 803276
- Other IDs
- 2023209
- Acronym
- NAD-HD
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06853743
- Acronym / sponsor ID
- NAD-HD / 803276
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, Nicotinamide riboside, Vitamin B3, NAD, Neuroprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, South-Eastern Norway Regional Health Authority, Klinbeforsk, The Dam Foundation, Elysium Health, NKS Olaviken Gerontopsychiatric Hospital
- Study start
- 18 Mar 2025 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide riboside | Experimental | Dietary Supplement: Nicotinamide Riboside (NR)Nicotinamide riboside, 2 capsules of 500mg twice daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNicotinamide riboside, 2 capsules twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- 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.
- Established coronary artery disease or clinically significant cerebrovascular disease as deemed by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide Riboside (NR)Nicotinamide riboside, 2 capsules of 500mg taken twice daily for 2 years | Dietary supplement | Nicotinamide riboside |
| PlaceboPlacebo, 2 capsules twice daily for 2 years | Dietary supplement | Placebo |
Primary outcome
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)
The cUHDRS is a composite outcome measure comprised of motor, cognitive and global functional components. It is calculated as an equally weighted sum of Z-scores, with lower scores indicating greater clincial burden of HD symptoms.
4 secondary outcomes
Number of Participants with Adverse Events
Time frame: From baseline to the end of treatment at 730 days
Change from Baseline in the Unified Huntington's Disease Total Motor Score at 730 days
Time frame: From baseline to the end of treatment ao 730 days
Change from Baseline in the Montreal Cognitive Assessment at 730 days
Time frame: From baseline to the end of treatment at 730 days
Change from baseline in the Hospital Anxiety and Depression Scale/Snaith Irritability Scale (HADS-SIS) at 730 days
Time frame: From baseline to the end of treatment at 730 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lasse Pihlstrøm, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside (NR) in people with Huntington Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen H Maurtveten, BSc (+47 95143795, emaurtve@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.