NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment

NCT ID: NCT03482167

Last Updated: 2025-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2024-01-22

Brief Summary

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This study will provide insight into whether a nutritional supplement, nicotinamide riboside (NR), improves memory and brain blood flow in older adults with low memory abilities. Overall, this project has the potential to identify a novel, safe and cost-effective strategy for decreasing age-related memory loss.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo

Nicotinamide Riboside

Niagen® (ChromaDex, Inc.) 500 mg, twice daily

Group Type EXPERIMENTAL

Niagen®

Intervention Type DRUG

250 mg capsules (4 capsules daily)

Interventions

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Niagen®

250 mg capsules (4 capsules daily)

Intervention Type DRUG

Placebo

placebo

Intervention Type OTHER

Other Intervention Names

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nicotinamide riboside chloride

Eligibility Criteria

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Inclusion Criteria

* Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation;
* age 60-90 years;
* MMSE score \>24 at time of initial consent;

Exclusion Criteria

* blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function; estimated glomerular filtration rate using the MDRD prediction equation must be \>30 ml/min/1.73 m2;
* any clinically significant abnormal blood chemistry values as determined by the research nurse or NMPCC nurse practitioner;
* major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);
* neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, mild or severe traumatic brain injury, large vessel infarct);
* concussion within last 2 years and ≥ 3 lifetime concussions;
* current systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure);
* prior history of any type of cancer;
* substance abuse or dependence (DSM-V criteria);
* current use of medications used to treat dementia (e.g., anticholinesterase drugs) or other drugs likely to affect cognition (e.g., anticholinergic drugs, long-acting benzodiazepines);
* claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning\*;
* current smoking (including marijuana) within the past 3 months;
* hospitalization as a result of COVID-19
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Christopher Martens

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher R Martens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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Neurovascular Aging Laboratory

Newark, Delaware, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K01AG054731

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1079271

Identifier Type: -

Identifier Source: org_study_id

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