Alzheimer's Disease Trial, Recruiting NCT05245903 Sponsor: Mclean Hospital Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Recruiting

NCT05245903
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand the purpose and risks of the study, and who are willing to provide signed, dated consent to participate and to share relevant health information
  • People who speak and read English fluently
  • People aged 18 to 89 years old (inclusive)
  • People with normal hearing and vision, or hearing and vision that is corrected to normal (for example, with hearing aids or glasses)
  • People who have received a clinical diagnosis of Mild Cognitive Impairment (MCI) or Mild Alzheimer's Disease, based on specific diagnostic criteria used by the trial
  • People who have a study partner available to participate alongside them for the full duration of the trial
  • People who carry at least one copy of a specific gene variant called APOE ε4
  • People whose calculated risk score is above 4, based on a specific risk assessment method developed by researchers in 2017
  • People who take niacin (vitamin B3) — including through a vitamin supplement — at a dose above 200mg per day, and who have completed a two-week period of stopping that supplement before joining the trial

Who may not be able to join:

  • People with a serious or unstable medical or neurological condition that could affect thinking or memory, as assessed by the study doctor
  • People who have had an unstable mood or anxiety disorder within the six months before screening, as assessed by the study doctor
  • People with a lifetime history of a psychotic disorder, such as Schizophrenia or Schizoaffective Disorder, as assessed by the study doctor
  • People who have been diagnosed with a mitochondrial disorder
  • People who have any medical condition or implant that makes MRI scanning unsafe for them
  • People who have had a known allergic reaction or sensitivity to NR (Nicotinamide Riboside, the supplement being studied in this trial)
  • People who have had a mini-stroke (transient ischemic attack) or stroke within the past year
  • People with a history of alcohol or substance misuse within the past year, as assessed by the study doctor and a urine test
  • People with a history of a moderate or severe head injury, as defined by DSM-5 medical criteria
  • People who have had a seizure within the past 10 years
  • People currently taking medications known to affect thinking or memory, including certain sedatives, painkillers, antipsychotics, or antihistamines (confirm with trial site for the full list)
  • People whose dose of any psychiatric medication has changed within four weeks before the screening visit
  • People who have previously used L-DOPA, any Parkinson's disease medication, or any anti-amyloid immunotherapy treatment
  • People currently using supplements or medications intended to support mitochondrial function or act as antioxidants, such as carnitine, creatine, Co-Q10, N-acetyl cysteine, or pramipexole
  • People who have started or changed their dose of Alzheimer's medications (such as acetylcholinesterase inhibitors or memantine) within four weeks before the screening visit
  • People who have used prescription opioid (narcotic) medications within four weeks before the screening visit
  • People who are currently pregnant or breastfeeding
  • People who have used niacin or a niacin-containing vitamin supplement at a dose above 200mg within the two weeks before the study visit, and who have not completed the required two-week wash-out period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 617-855-2300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Mclean Hospital
Registry
ClinicalTrials.gov
Start date
31 May 2022
Est. completion
31 May 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Sleep efficiency; Longitudinal time series of gait speed measurements; Diurnal rhythm

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov