What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease that aim to enhance brain energy metabolism and reduce oxidative stress include nicotinamide and its derivatives, such as Nicotinamide Riboside. These treatments are generally well-tolerated, but potential side effects can include gastrointestinal issues like nausea and diarrhea, as well as headaches and fatigue. Other common Alzheimer's treatments, such as cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine), may cause side effects like nausea, vomiting, loss of appetite, increased frequency of bowel movements, dizziness, and confusion.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). These drugs aim to manage symptoms by enhancing neurotransmitter function rather than directly targeting brain energy metabolism or oxidative stress. While newer treatments like aducanumab focus on amyloid-beta reduction, there is limited information on FDA-approved drugs that specifically enhance NAD+ levels or directly improve brain energy metabolism and reduce oxidative stress, similar to the approach being studied with Nicotinamide Riboside.

What other types of research exist?

Promising alternatives to Nicotinamide Riboside for Alzheimer's Disease patients include Exendin-4, which attenuates brain mitochondrial toxicity through the PI3K/Akt pathway, and ultra-high-dose methylcobalamin, which has shown neuroprotective effects in other neurodegenerative conditions.

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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 and 12 weeks, pre- and post- 1000 mg nr daily for reporting.

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 more

Awards & 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

0 / 14Eligibility criteria met

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.