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

NCT05617508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Placebo

Placebo capsules administered twice daily for a total of 12 weeks.

DIETARY_SUPPLEMENT

Nicotinamide Riboside supplementation 1000mg daily in total

Nicotinamide Riboside supplementation 1000mg daily in total

DIETARY_SUPPLEMENT

Nicotinamide Riboside dose escalation (up to 3000 mg daily in total)

Nicotinamide Riboside supplementation up to 3000mg daily in total

Sponsors & Collaborators

  • Haraldsplass Deaconess Hospital

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Kristoffer Haugarvoll, MD, PhD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2025-06-05
Completion
2025-06-05

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617508 on ClinicalTrials.gov