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Vitamin
Nicotinamide Riboside for Alzheimer's Disease
Phase < 1
Recruiting
Led By Brent Forester, MD, MSc
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal or corrected to normal hearing and vision
Ability of the participant and/or his/her legally authorized representative to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information
Must not have
Current use of putative mitochondrial enhancers and antioxidants
Prior use of L-DOPA, anti-Parkinsonian medication, or anti-amyloid immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 and 12 weeks, pre- and post- 1000 mg nr daily
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing nicotinamide riboside (NR), a form of vitamin B3, to see if it can help people with early memory problems or mild Alzheimer's. The idea is that NR can boost a molecule called NAD+ in the brain, which helps cells produce energy and reduces stress. Researchers hope this will improve brain function in these patients. Nicotinamide riboside (NR) is a precursor to NAD+ and has shown potential in improving learning and memory in animal models of dementia.
Who is the study for?
This trial is for individuals aged 55-89 with mild cognitive impairment or mild Alzheimer's dementia, who can understand study risks and consent. They must speak English fluently, have a study partner, carry the APOE ε4 allele or show positive AD biomarkers. Exclusions include serious medical conditions affecting cognition, recent mood disorders, psychotic history, MRI contraindications, NR intolerance, recent strokes or substance abuse.
What is being tested?
The trial tests whether Nicotinamide Riboside (NR) improves brain energy metabolism and reduces oxidative stress in patients with mild cognitive impairment or Alzheimer's dementia. It aims to see if NR can enhance cognitive function by supplementing the body's energy molecules.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of Nicotinamide Riboside may include nausea, fatigue, headaches, diarrhea stomach discomfort and indigestion based on its known profile.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hearing and vision are normal or corrected to normal.
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I understand the study's risks and goals, and I can sign the consent form.
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I am between 55 and 89 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking supplements to boost my mitochondria or antioxidants.
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I have taken L-DOPA, anti-Parkinsonian drugs, or anti-amyloid treatments.
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I have a serious health or brain condition affecting my thinking.
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I have had a seizure in the last 10 years.
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My mood or anxiety has been stable for the last 6 months.
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I have been diagnosed with a mitochondrial disorder.
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I have had a stroke or a mini-stroke recently.
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I have taken more than 200mg of niacin daily in the last two weeks.
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I have or had cancer at some point in my life.
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I am taking medication that affects my thinking or memory.
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I have had a moderate or severe head injury in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 and 12 weeks, pre- and post- 1000 mg nr daily
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 and 12 weeks, pre- and post- 1000 mg nr daily
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in brain NAD+
Changes in brain redox state
Secondary study objectives
Changes in antioxidant glutathione (GSH) levels
Changes in mitochondrial function
Other study objectives
Changes in behavioral or psychiatric symptoms resulting from memory problem
Changes in cognitive status
Changes in functional status
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mild Cognitive Impairment and Alzheimer's DementiaExperimental Treatment1 Intervention
Participants will take 4 pills every day, each containing 250 mg NR (NIAGEN® by Chromadex; www.chromadex.com), via the oral route, for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide riboside
2021
Completed Phase 3
~390
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) that enhance brain energy metabolism and reduce oxidative stress include Nicotinamide Riboside (NR), which increases NAD+ levels to support cellular energy production and mitigate oxidative damage. This is crucial for AD patients as it may improve cognitive function and slow disease progression.
Antioxidants like Vitamin E also aim to reduce oxidative stress, while cholinergic system modulators like Vitamin B12 help maintain neurotransmitter function and blood-brain barrier integrity. These treatments are significant because they address the core pathophysiological processes of AD, potentially leading to better patient outcomes.
Vitamin B12 as a cholinergic system modulator and blood brain barrier integrity restorer in Alzheimer's disease.Redox signaling and Alzheimer's disease: from pathomechanism insights to biomarker discovery and therapy strategy.Nicotinamide and neurocognitive function.
Vitamin B12 as a cholinergic system modulator and blood brain barrier integrity restorer in Alzheimer's disease.Redox signaling and Alzheimer's disease: from pathomechanism insights to biomarker discovery and therapy strategy.Nicotinamide and neurocognitive function.
Find a Location
Who is running the clinical trial?
Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,823 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,784 Previous Clinical Trials
28,184,373 Total Patients Enrolled
Brent Forester, MD, MScPrincipal InvestigatorMclean Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking supplements to boost my mitochondria or antioxidants.I have taken L-DOPA, anti-Parkinsonian drugs, or anti-amyloid treatments.I have a serious health or brain condition affecting my thinking.I have had a seizure in the last 10 years.My mood or anxiety has been stable for the last 6 months.I haven't taken prescription painkillers in the last 4 weeks.I recently started or changed the dose of my Alzheimer's medication.I have been diagnosed with a mitochondrial disorder.I have recently changed the dose of my psychiatric medication.I have had a stroke or a mini-stroke recently.I have taken more than 200mg of niacin daily in the last two weeks.I have or had cancer at some point in my life.My hearing and vision are normal or corrected to normal.I understand the study's risks and goals, and I can sign the consent form.I have mild cognitive impairment or Alzheimer's, with specific diagnosis criteria met.I am between 55 and 89 years old.I am taking medication that affects my thinking or memory.I have had a moderate or severe head injury in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Mild Cognitive Impairment and Alzheimer's Dementia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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