Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT05245903
Eligibility Criteria:
Inclusion 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
* 18-89 years old (inclusive)
* Normal or corrected to normal hearing and vision
* Meet clinical diagnostic criteria for MCI or Mild AD, according to the criteria outlined above
* Study partner available for duration of trial participation
* At least one copy of the APOE ε4 allele
* 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 Criteria:
* 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, 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 or antioxidants (e.g. carnitine, creatine, Co-Q10, N-acetyl cysteine, pramipexole)
* Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of screening
* Prior use of prescription narcotics 4 weeks before screening
* Female subjects who are pregnant or breastfeeding
* The current use of niacin (or a vitamin supplement with niacin) \>200mg within the last two weeks prior to study visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT05245903
Study Brief:
Protocol Section:
NCT05245903