Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia

Who is this study for? Patients with mild cognitive impairment and mild Alzheimer's dementia
What treatments are being studied? Nicotinamide riboside
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain energy metabolism, oxidative stress, and cognitive function in individuals with mild cognitive impairment (MCI) and mild Alzheimer's dementia (AD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 89
Healthy Volunteers: f
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• 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.

• Ability to speak and read fluently in English

• 55-89 years old (inclusive)

• Normal or corrected to normal hearing and vision

• Meet clinical diagnostic criteria for MCI or Mild AD, according to the following criteria:

‣ CDR Global Score of 0.5 (MCI) or 1.0 (mild AD)

⁃ 2018 NIA-AA guidelines for MCI/mild AD

• Study partner available for the duration of trial participation

• At least one copy of the APOE ε4 allele or AD+ including Amyloid positive PET scan, Tau positive PET Scan (MK6240 et al.), or CSF AD biomarkers \[i.e., amyloid-beta beta (Aβ42) total (T)-tau, and phosphorylated (P)-tau\]

• An aggregate risk score \> 4 according to the risk analysis method developed by Sabbagh et al. (2017)

• For individuals who are taking niacin (or a vitamin supplement with niacin) of \>200mg, the completion of a two-week wash-out period

Locations
United States
Massachusetts
McLean Hospital
RECRUITING
Belmont
Contact Information
Primary
Fei Du, PhD
fdu@mclean.harvard.edu
6178552710
Time Frame
Start Date: 2022-03-02
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 50
Treatments
Experimental: Mild Cognitive Impairment and Alzheimer's Dementia
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.
Related Therapeutic Areas
Sponsors
Leads: Mclean Hospital
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov