N-DOSE AD: A Dose Optimization Trial of Nicotinamide Riboside in Alzheimer's Disease

Plain-language summary

This study investigates the most suitable dose of the supplement Nicotinamide Riboside in people with Alzheimer's disease and uses a placebo for comparison. People aged 50 to 85 with a diagnosis of probable Alzheimer's disease per guideline criteria who were suitable for certain examinations could take part. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Haukeland University Hospital

Intervention

Placebo, Nicotinamide Riboside supplementation 1000mg daily in total, Nicotinamide Riboside dose escalation (up to 3000 mg daily in total)

Start date

11/22/2022

Estimated completion

6/5/2025

Countries

Norway

Related genes

Locations

• Bergen, Norway
• Bergen, Norway

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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)

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

* Diagnosis of dementia other than probable AD.
* Comorbidity that precludes study participation or data interpretation.
* 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.
* Use of high dose vitamin B3 supplementation within 30 days of enrollment.
* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
* Current treatment with Oral Anti-coagulation Therapies
* Implants that preclude MRI examinations, e.g. DBS, pacemaker