NCT05617508CompletedPhase 2
N-DOSE AD: A Dose Optimization Trial of Nicotinamide Riboside in Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
The goal of this double-blinded placebo-controlled randomized trial is to determine the optimal dose of nicotinamide riboside (NR), in individuals with Alzheimer's disease (AD). The main questions the N-DOSE AD trial aims to answer are: What dose of nicotinamide riboside (NR) is required to achieve maximal cerebral nicotinamide adenine dinucleotide (NAD) increase, measured by 31P-magnetic resonance spectroscopy (MRS) or cerebrospinal fluid (CSF) metabolomics)? What dose of nicotinamide riboside (NR) is required to achieve maximal alteration in the cerebral metabolism patterns, measured by fluorodeoxyglucose-positron emission tomography (FDG-PET)? What dose of nicotinamide riboside (NR) will have optimal effect in the absence of unacceptable toxicity? Participants will be asked to do participate in: Clinical examinations Cognitive assessments Lumbar puncture Magnetic resonance imaging - positron emission tomography (MRI-PET) scannings Biosampling They'll be given placebo, 1000 mg NR or escalating doses of NR (1000 mg - 2000 mg - 3000 mg) over 12 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 22 Nov 2022
- Primary completion date
- 5 Jun 2025
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT05617508
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 22 Nov 2022 to the primary completion date, 5 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with Oral Anti-coagulation Therapies
- Implants that preclude MRI examinations, e.g. DBS, pacemaker
Other illness
- Diagnosis of dementia other than probable AD.
- Any psychiatric disorder that would interfere with compliance in the study.
- Any severe somatic illness that would interfere with compliance and participation in the study.
- Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
Other
- Patients will be excluded from the study if they meet any of the following criteria:
- Comorbidity that precludes study participation or data interpretation.
- Use of high dose vitamin B3 supplementation within 30 days of enrollment.
Who the study is looking for
- The following condition must apply to the prospective patient at screening prior to receiving study agent:
- Diagnosis of probable Alzheimer Disease (AD) according to the core clinical criteria updated in the National Institute on Aging (NIA) and Alzheimer's Association guidelines.
- Biomarker evidence consistent with AD neuropathologic change, defined by cerebrospinal fluid (CSF) markers.
- Diagnosed with AD within two years from enrollment.
- Clinical Dementia Rating (CDR) 0.5-1 (inclusive) at enrollment.
- Age 50 to 85 years (inclusive) at the time of enrollment.
- A study partner (i.e. a family member or a friend) able to provide study data and assist the participant in the study drug administration, i.e. contact ≥ 3 times weekly.
- 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 we will ask for an independent evaluation by a consultant clinician who is not associated with the N-DOSE AD study.
- Cholinesterase inhibitors and memantine can be used if stable for 8 weeks prior to baseline visit.
- Able to undergo lumbar puncture.
- Able to undergo magnetic resonance imaging (MRI)
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Haraldsplass Deaconess Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.