A dose optimisation trial of nicotinamide riboside in Alzheimer's disease
Information about the dietary supplement that will be tested in the study
Administration
Oral capsules twice daily
Will all participants receive the same dietary supplement ?
Participants will be selected at random to either receive one of the following options:
- Capsules of nicotinamide riboside (same dose 1000mg daily)
- Capsules of nicotinamide riboside (escalating dose 1000, 2000 and finally 3000mg daily)
- Capsules of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the dietary supplement being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the dietary supplement or not.
Information about participating in the study
What are the researchers trying to find out?
The purpose of the study is to evaluate the safety and determine the optimal dose of nicotinamide riboside in people with Alzheimer’s disease.
How long will the study last?
3 months
What your involvement will entail?
- During the study, participants will have to complete some laboratory/biological tests to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drugs tested in the study)
- Complete different study assessments that will evaluate memory, behaviour, cognition, activities of daily living, depression, orientation (ADAS-COG, CDR-SB, MOCA, NPI)
- Participants will have to complete brain scans (MRI, PET) and lumbar puncture (CSF).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 50 to 85 years old
- Have a diagnosis of probable Alzheimer's disease according to the National Institute on Aging (NIA) and Alzheimer's Association guidelines within two years
- Have results of lumbar puncture (spinal tap) with findings consistent with a diagnosis of Alzheimer's disease
- Have a score of 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR) at enrolment suggesting that the person has an impairment in his/her memory that is at very mild stage
- Have performed Montreal Cognitive Assessment (MoCA) or Mini Mental State Evaluation (MMSE) test within 6 months prior to baseline with a score ≥ 16 or ≥ 20 respectively. This would suggest an impairment at very mild stage in the memory
- Have a study partner who has a sufficient contact with the participant (≥ 3 times weekly), is willing to participate in study procedures throughout the study duration and assist the participant in the study drug administration
- If the person is taking approved symptomatic medication for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must have been stable for 8 weeks prior to baseline visit
- Be able to undergo lumbar puncture and brain scans (MRI).
Who cannot participate in the study?
People cannot take part in the study if they have:
- A diagnosis of dementia other than probable Alzheimer’s disease
- An unstable medical condition that may interfere with the safety, tolerability and/or study assessments (e.g. psychiatric disorder, severe somatic illness)
- Use of high dose vitamin B3 supplementation within 30 days
- Current treatment with oral anti-coagulation therapies, that may interfere with the safety, tolerability and/or study assessments
- Any contraindication to brain scans (i.e. implants such as pacemaker or electrodes for brain stimulation).
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT05617508
Study contact information
Kristoffer Haugarvoll +4798266741
kristoffer.haugarvoll@helse-bergen.no
Link to full text
https://clinicaltrials.gov/ct2/show/NCT05617508
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2023.
This document has been reviewed by the institution running this trial.
