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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 and 12 weeks, pre- and post- 1000 mg nr daily
Awards & highlights

Study Summary

This trial will study the effect of nicotinamide riboside on energy metabolism, oxidative stress, and cognitive function in people with mild cognitive impairment or mild Alzheimer's 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in brain NAD+
Changes in brain redox state
Secondary outcome measures
Changes in antioxidant glutathione (GSH) levels
Changes in mitochondrial function
Other outcome measures
Changes in behavioral or psychiatric symptoms resulting from memory problem
Changes in cognitive status
Changes in functional status
+2 more

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
~400

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,644 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,855 Total Patients Enrolled
Brent Forester, MD, MScPrincipal InvestigatorMclean Hospital

Media Library

Nicotinamide riboside (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04430517 — Phase < 1
Alzheimer's Disease Research Study Groups: Mild Cognitive Impairment and Alzheimer's Dementia
Alzheimer's Disease Clinical Trial 2023: Nicotinamide riboside Highlights & Side Effects. Trial Name: NCT04430517 — Phase < 1
Nicotinamide riboside (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04430517 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you refer to any other research projects which have utilized Nicotinamide riboside?

"Currently, 15 active trials involving Nicotinamide riboside are taking place with one of them in the late stages (Phase 3). These various studies span 19 locations across America and a notable concentration is found in Iowa City."

Answered by AI

Is entry to the study contingent upon a certain age restriction?

"Patients who hope to be included in this medical trial must fall between the ages of 55 and 89; as an alternative, there are also 55 trials available for those below 18 years old, and 1127 studies open to participants over 65."

Answered by AI

How many participants are being enrolled in this trial?

"Affirmative. Clinicaltrials.gov records confirm that recruitment for this medical study is occurring, which was first announced on March 2nd 2022 and recently amended on the 8th of the same month. The trial requires 50 participants from a single site."

Answered by AI

Is it possible for me to become part of this medical research?

"This clinical trial will enrol 50 individuals with Mild cognitive impairment (MCI) between 55 and 89 years of age. In order to be eligible, participants must possess the ability to understand its purpose and associated risks; provide signed informed consent that authorizes their confidential medical information being used; have an aggregate risk score higher than 4 according to Sabbagh et al's analysis method from 2017; fluency in English; normal hearing/vision abilities or corrected normal vision/hearing capabilities; a Clinical Dementia Rating Global Score of 0.5 if MCI is indicated or 1.0 for mild Alzheimer's disease (AD); fulfil 2018"

Answered by AI

Are participants still being recruited for this experimental research?

"Per the information provided on clinicaltrials.gov, this trial is presently enrolling participants. It was first made available to the public in March 2nd 2022 and its last update was recorded 8 days later."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
McLean Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia
Fei Du 2022. "Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430517.
All > Mci > Mild Cognitive Impairment
~16 spots leftby Apr 2025
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