Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment

NCT04078178 | Completed Results

• 1 other identifier: 2019P002668
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study we want to learn more about whether taking Niagen, a daily supplement containing a form of Vitamin B3, will improve cognitive function, mood, and daily activity in people with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI).

Conditions

Cognition Disorders in Old Age; Mild Cognitive Impairment; Cognitive Decline

Keywords

Mild Cognitiive Impairment; Subjective Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

  The primary outcome of this study will be objective measures of cognitive performance measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, crossover, and the end of study. RBANS has a mean score of 100 with a standard deviation of 15. Scores range from 40 to 160. Higher scores indicate normal cognition.

  From baseline through end of study at 16 weeks

Study Arms (2)

Sequence 1: Active Niagen, Placebo

EXPERIMENTAL

Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks.

Dietary Supplement: Niagen; Dietary Supplement: Placebo Comparator

Sequence 2: Placebo, Active Niagen

EXPERIMENTAL

Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks.

Dietary Supplement: Niagen; Dietary Supplement: Placebo Comparator

Interventions

Niagen DIETARY_SUPPLEMENT

Nicotinamide Riboside

Sequence 1: Active Niagen, Placebo; Sequence 2: Placebo, Active Niagen

Placebo Comparator DIETARY_SUPPLEMENT

Placebo

Sequence 1: Active Niagen, Placebo; Sequence 2: Placebo, Active Niagen

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 60 and up;
• Memory and other cognitive complaints consistent with SCD or MCI as defined by the National Institute on Aging:
• a. SCD will be defined as: i. any subjective concern of change in cognitive functioning without objective evidence of cognitive impairment, and ii. complete preservation of functional abilities and independence in instrumental activities of daily living.
• b. MCI will be defined as: i. a preexisting diagnosis of MCI given by a trained physician or behavioral health provider, or ii. evidence of objective impairment in cognitive functioning in one or more domain with preservation of functional abilities and independence in instrumental activities of daily living as defined by the National Institute on Aging;
• Minimum score of 16 on t-MoCA;
• Ability to provide direct informed consent as assessed by obtaining a score of 70% on questions 1-10, and answer 'yes' to questions 11-14 of the Informed Consent Worksheet after two attempts;
• Education level, English language skills and literacy indicates participant able to complete all assessments;
• Willing and able to complete all assessment and study procedures;
• Not pregnant, lactating, or of child-bearing potential;
• If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline.

You may not qualify if:

• Any specific CNS disease history other than suspected ADRD, such as major clinical stroke, brain tumor, normal pressure hydrocephalus, multiple sclerosis, significant head trauma with persistent neurological of cognitive deficits or complaints;
• Any impairment in instrumental activities of daily living that would indicate a level of cognitive impairment beyond MCI as assessed by a trained rater;
• Clinically significant unstable medical condition that could affect safety or compliance with the study and would, in the opinion of the investigator, pose a risk to the participant if they were to participate in the study;
• History of neuroimaging with evidence of major infarction, injury, infection, or other focal lesions that may be related to cognitive dysfunction;
• If participating in the optional lumbar puncture sub-study, any contraindication to undergo lumbar punctures, such as:
• abnormal coagulation PT/INR test result, outside of the normal range of 0.9 to 1.2 platelet counts below 50,000 (determined by a licensed study physician or Nurse Practitioner after reading test results).
• Platelet counts below 50,000.
• Use of Coumadin, Warfarin, or other blood thinner medications.
• Infection near the puncture site, or spinal column deformities (a licensed physician or Nurse Practitioner will examine the site visually for infection or spinal deformities before performing the procedure).
• Known allergy to Lidocaine.
• Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
• Current suicidal ideation or history of suicide attempt;
• History of alcohol or other substance abuse or dependence within the past two years;
• Any significant systemic illness or medical condition that could affect safety or compliance with study;
• Laboratory abnormalities in Vitamin B12, Thyroid Stimulating Hormone (TSH), or other common laboratory parameters that might contribute to cognitive dysfunction or other abnormalities in hematological, hepatic or renal function tests;

Sponsors & Collaborators

• Steven E Arnold, MD: lead

Study Sites (1)

Alzheimer's Clinical and Translational Research Unit

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Kayla McEachern
• Organization: MGH

kmceachern2@mgh.harvard.edu

617-643-5265

Study Officials

• Steven Arnold, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized into 2 Treatment sequences, one starting with Placebo followed by Niagen; and the other sequence starting with Active Niagen and followed by Placebo.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 4, 2019
• Study Start: October 30, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)