The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared Wi… (NCT06853743) | Clinical Trial Compass
RecruitingPhase 2
The NAD-HD Study: A Study to Investigate Efficacy and Safety of Nicotinamide Riboside Compared With Placebo in Huntington's Disease
Norway120 participantsStarted 2025-03-18
Plain-language 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. 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the composite Unified Huntington's Disease Rating Scale at 730 days
Timeframe: From baseline to the end of treatment at 730 days (2 years)