Nicotinamide Riboside by Mouth for Early Alzheimer’s Disease (2-Year Trial)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with early Alzheimer's disease will be randomly assigned to nicotinamide riboside or a placebo for two years. Participants will have clinic visits every 26 weeks to monitor safety and cognitive status. The trial uses the Clinical Dementia Rating scale to measure progression and relies on biomarker criteria to confirm Alzheimer’s pathology. Safety and tolerability will also be monitored throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Haraldsplass Deaconess Hospital
  Bergen, Norway Recruiting
• Haukeland University Hospital
  Bergen, Norway Not yet recruiting

Study contacts

• Study coordinator: Kristoffer Haugarvoll, MD, PhD
• Email: kristoffer.haugarvoll@helse-bergen.no
• Phone: 47-55975045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.