Alzheimer Disease (AD)Phase 2N-ADNCT07741071
N-AD: Orally Administered Nicotinamide Riboside Over Two Years as a Potential Disease Modifying Treatment for Alzheimer's Disease
A Phase 2 study testing Nicotinamide Riboside (NR) and Palacebo in people with Alzheimer Disease (AD), run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
The goal of this clinical trial is to learn if orally administered nicotinamide riboside works to slow the progression of early Alzheimer disease in adults. It will also learn about the safety of drug nicotinamide riboside. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- Nicotinamide Riboside (NR) and Palacebo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 2 sitesNorway
- Study dates
- 26 Aug 2026to 30 Apr 2030
- Phase
- Phase 2
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis Early clinical AD, e.g. Stage 3 MCI or Stage 4 (mild AD dementia), as defined by the FDA, 2024.
- Biomarker evidence consistent with AD neuropathologic change, defined by CSF markers, i.e. Aβ42 < 1030 ng/L and P-tau181/Aβ42 > 0,023 ng/L and/or T-tau/Aβ42 > 0,28 ng/L* or AD amyloid biomarker (as determined either by visual reading of amyloid PET scans using an approved ligand
- Diagnosed with AD within 2 years from baseline.
- Capacity to provide written informed consent for study participation defined as Montreal Cognitive Assessment (MoCA) score ≥ 16 or Mini Mental State Evaluation (MMSE) score ≥ 20. MMSE or MoCA must have been performed within 6 months prior to baseline. If there is any doubt regarding the participants capacity to give informed consent, this will be determined by an evaluation by a consultant clinician who is not associated with the N-AD study.
- Global CDR(33) 0.5-1 (inclusive) at enrollment.
- Age 50 to 85 years (inclusive) at the time of enrollment.
- A study partner with sufficient contact to be able to provide data on ADLs and assist the participant in study drug administration. -
- Cholinesterase inhibitors and memantine can be used if stable for 8 weeks prior to baseline visit.
Who cannot join
- Diagnosis of dementia other than probable AD.
- Abundant vascular pathology, i.e. Fazekas >2. or >3 lacunar infarcts, stroke involving a major vascular territory, severe small vessel, or white matter disease
- More than 1 core feature of dementia with Lewy bodies, i.e; recurrent visual hallucination, cognitive fluctuations, REM sleep behaviour disorder, one or more spontaneous cardinal features of parkinsonism (tremor, rigidity and bradykinesia).
- Comorbidity that precludes study participation or data interpretation.
- Any psychiatric disorder that would interfere with compliance in the study.
- Use of high dose vitamin B3 supplementation within 30 days of baseline.
- Any active neoplastic malignancy (other than non-metastatic dermatological conditions) within two years of the screening visit or current clinically significant haematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease. Active neoplastic malignancy is defined as having a known malignant focus and/or receiving anti-cancer treatment. For the non-cancer conditions, if the condition has been stable for at least the one year before the screening visit and/or is judged by the site investigator not to interfere with the subject's participation in the study, the subject may be included.
- Inability to undergo MRI or to comply with study procedures.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Haraldsplass Deaconess Hospital
Bergen, 5009
Lone B Johansen, 47-48269834, lone.birkeland.johansen@haraldsplass.no
Kristina Skeie, 47-48268344, kristina.skeie@haraldsplass.no
- Not yet recruiting
Haukeland University Hospital
Bergen, 5021
Kristoffer Haugarvoll, MD, PhD, 47-55975045, kristoffer.haugarvoll@helse-bergen.no
Kristoffer Haugarvoll, MD, PhD
About this study
Official title: N-AD: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Phase 2 Trial of Orally Administered Nicotinamide Riboside Over Two Years as a Potential Disease Modifying Treatment for Alzheimer's Disease
The goal of this clinical trial is to learn if orally administered nicotinamide riboside works to slow the progression of early Alzheimer disease in adults. It will also learn about the safety of drug nicotinamide riboside. The main questions it aims to answer are:
- Does drug nicotinamide riboside slow the progression of Alzheimer disease as measured by the Clinical Dementia Rating scale.
- What medical problems do participants have when taking drug nicotinamide riboside? Researchers will compare drug nicotinamide riboside to a placebo (a look-alike substance that contains no drug) to see if nicotinamide riboside works to treat early Alzheimer disease.
Read more
Participants will:
- Take drug nicotinamide ribosie or a placebo every day for 24 months
- Visit the clinic once every 26 weeks for checkups and tests
- Conditions
- Alzheimer Disease (AD)
- Being tested
- Nicotinamide Riboside (NR), Palacebo
- Keywords
- Alzheimer's Disease (AD), mild cognitive impairment, Nicotinamide riboside, Dementia, Placebo controlled
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (NR)Dietary supplement
Also called NR, TruNiagen
Nicotinamide Riboside 1000mg administered two times a day. Given as capsules. Duration of the trial; 104 weeks.
PalaceboOther
Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 104 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide Riboside (NR) | Experimental | Nicotinamide riboside, 2000 mg for the duration of the trial (104 weeks). Dosage form is capsules. Receives: Dietary Supplement: Nicotinamide Riboside (NR) |
| Placebo | Placebo comparator | Placebo capsules, no active ingredients. Receives: Other: Palacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity assessed by the Clinical Dementia Rating scale (CDR) sum of boxes.
CDR is a scale assessing clinical impairment in AD. CDR integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following semi-structured caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology (CDR-SB) sums the score for each of the 6 domains and provides a value ranging from 0 to 18 with higher scores indicating greater impairment.
Positive change from baseline indicates greater impairment.
Measured: From baseline to the end of treatment at 104 weeks.
Secondary outcomes (6)
Change from baseline in the MoCA score at Week 104.
MoCA is a validated global measure of cognitive ability. The MoCA scale ranges from 0 - 30. Lower scores indicate cognitive impairment.
Measured: From baseline to the end of treatment at 104 weeks.
Change from baseline in Amsterdam ADL scale short version (A-IADL-Q-SV) at Week 104.
The Amsterdam ADL scale short version (A-IADL-Q-SV) is a 30-item, proxy-completed, psychometrically validated instrument designed to measure functional decline in instrumental activities of daily living (IADL). Lower scores reflect greater impairment.
Measured: From baseline to the end of treatment at 104 weeks
Change from baseline in delayed recall performance on the CERAD 10-Word List at Week 104
CERAD 10-Word List Test evaluates memory. Higher scores reflect better performance.
Measured: From baseline to the end of treatment at 104 weeks.
Change from baseline in executive functioning as measured by Trail-Making Test Part B completion time at Week 104
Trail-Making Test B (TMT-B) measures executive function. Score = Time to Completion. Maximumt time in this trial is 360 sekunds. Longer time reflects greater impairment.
Measured: From baseline to the end of treatment at 104 weeks.
Change from baseline in verbal fluency as measured by the COWAT (total correct words for F, A, S) at Week 104.
The Controlled Oral Word Association Test (COWAT) F A S version assesses verbal fluency. The total score is simply the count of all valid, non-repeated, rule-adherent words. Higher scores reflect better performance.
Measured: From baseline to the end of treatment at 104 weeks.
Change from baseline in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at Week 104.
The NPI-Q measures the burden of 12 neuropsychiatric symptoms of dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating. Symptom severity is rated on a 3-point scale with higher scores indicating worse symptoms. Minimum score would be 0 and maximum score would be 36.
Measured: From baseline to the end of treatment at 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start26 Aug 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- 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
- Model description
- Randomized double-blinded study. N = 270 participants are randomized in a 1:1 ratio to either nicotinamide riboside (1000 mg x 2 per day) or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristoffer Haugarvoll, MD, PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741071
- Sponsor's protocol ID
- 481035
- Acronym
- N-AD
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No