RECRUITING

Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia

Conditions

Mild Cognitive Impairment Mild Alzheimer Disease Bioenergetics Mild Alzheimer's Dementia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-03-02

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04430517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: 1. CDR Global Score of 0.5 (MCI) or 1.0 (mild AD) 2. 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	* Current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician * Clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician * Lifetime history of psychotic disorder (i.e. Schizophrenia, Schizoaffective Disorder), as determined by study clinician * Diagnosis of a mitochondrial disorder * Any MRI safety contraindications * History of drug hypersensitivity or intolerance to NR * Transient ischemic attack or stroke within 1 year prior to screening * History of alcohol or substance abuse within prior year, as determined by study clinician and urine toxicology screen * History of head injury rated as moderate or worse, per DSM-5 criteria * History of seizure within prior 10 years * Current use of medication with known adverse effects on cognition (benzodiazepines, barbiturates, opiate analgesics, first generation antipsychotic medication, centrally acting anticholinergics, sedating antihistamines, tricyclic anti-depressants) * Change in dose of any psychiatric medications within 4 weeks of screening visit * Prior use of L-DOPA, any anti-Parkinsonian medication, or prior treatment with anti-amyloid immunotherapy * Current use of putative mitochondrial enhancers and antioxidants (e.g carnitine, creatine Co-Q10, N-acetyl cysteine \[NAC\], pramipexole) * Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of baseline visit * Prior use of prescription narcotics 4 weeks before baseline visit * Female subjects who are pregnant or breastfeeding * The use of current use of niacin (or a vitamin supplement with niacin) \>200mg within the last two weeks prior to study visit. * Current or lifetime history of cancer.

Inclusion Criteria

Exclusion Criteria

* 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:
1. CDR Global Score of 0.5 (MCI) or 1.0 (mild AD)
2. 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

* Current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician
* Clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician
* Lifetime history of psychotic disorder (i.e. Schizophrenia, Schizoaffective Disorder), as determined by study clinician
* Diagnosis of a mitochondrial disorder
* Any MRI safety contraindications
* History of drug hypersensitivity or intolerance to NR
* Transient ischemic attack or stroke within 1 year prior to screening
* History of alcohol or substance abuse within prior year, as determined by study clinician and urine toxicology screen
* History of head injury rated as moderate or worse, per DSM-5 criteria
* History of seizure within prior 10 years
* Current use of medication with known adverse effects on cognition (benzodiazepines, barbiturates, opiate analgesics, first generation antipsychotic medication, centrally acting anticholinergics, sedating antihistamines, tricyclic anti-depressants)
* Change in dose of any psychiatric medications within 4 weeks of screening visit
* Prior use of L-DOPA, any anti-Parkinsonian medication, or prior treatment with anti-amyloid immunotherapy
* Current use of putative mitochondrial enhancers and antioxidants (e.g carnitine, creatine Co-Q10, N-acetyl cysteine \[NAC\], pramipexole)
* Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of baseline visit
* Prior use of prescription narcotics 4 weeks before baseline visit
* Female subjects who are pregnant or breastfeeding
* The use of current use of niacin (or a vitamin supplement with niacin) \>200mg within the last two weeks prior to study visit.
* Current or lifetime history of cancer.

Contacts and Locations

Study Contact

Fei Du, PhD

CONTACT

6178552710

fdu@mclean.harvard.edu

Principal Investigator

Fei Du, PhD

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Brent Forester, MD, MSc

PRINCIPAL_INVESTIGATOR

Mclean Hospital

Study Locations (Sites)

McLean Hospital

Belmont, Massachusetts, 02478

United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Fei Du, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital
Brent Forester, MD, MSc, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-03-02

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

Mild Cognitive Impairment
Bioenergetics
Mild Alzheimer's Dementia

Additional Relevant MeSH Terms

Mild Cognitive Impairment
Mild Alzheimer Disease