Status:
RECRUITING
Effects of Nicotinamide Riboside on Bioenergetics and Oxidative Stress in Mild Cognitive Impairment/Alzheimer's Dementia
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Mild Alzheimer Disease
Eligibility:
All Genders
55-89 years
Phase:
EARLY_PHASE1
Brief 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 w...
Detailed Description
Mitochondrial function is mediated, in part, by nicotinamide adenine dinucleotide (NAD). Unfortunately, decreases in NAD+ levels are associated with normal aging, and also with numerous diseases such ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04430517
Start Date
March 2 2022
End Date
January 30 2026
Last Update
October 31 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478