Using niacin to treat Alzheimer's disease
Nicotinic Acid for the Treatment of Alzheimer's Disease
This study is testing if taking niacin can help people aged 60-85 with mild to moderate Alzheimer's disease by looking at how it affects their brain and overall health.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06582706 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the effects of extended-release niacin on patients with Alzheimer's disease by measuring its penetration into the cerebrospinal fluid. Participants aged 60-85 with mild to moderate dementia will receive either niacin or a placebo in a randomized, double-blind manner. The study will assess the levels of nicotinic acid in blood and cerebrospinal fluid, as well as the safety and tolerability of niacin. The goal is to establish a dose-response curve and evaluate the potential benefits of niacin in targeting neurodegenerative processes associated with Alzheimer's.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 60-85 with a clinical diagnosis of mild to moderate Alzheimer's disease.
Not a fit: Patients with contraindications to lumbar puncture or severe cerebrovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing Alzheimer's disease and improving cognitive function.
How similar studies have performed: While niacin has been explored in other contexts, this specific application for Alzheimer's disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 60-85 males or females Clinically have a diagnosis of Alzheimer's disease in the mild-moderate dementia range Mini Mental Status Examination (MMSE) between 14-24 inclusive Must be on a stable dose (30 days minimum) of a cholinesterase inhibitor and/or memantine (or absence thereof) Have a reliable co-participant who has at least 3 days of face-to-face contact per week with the patient and ensures medical compliance with the study drug. Neuroimaging (MRI or CT scan of the brain) should be available within 1 year of screening Exclusion Criteria: Any contraindication to clinical lumbar puncture including increased intracranial pressure, posterior fossa mass, bleeding diathesis, use of antiplatelet medications other than aspirin, use of any anticoagulant Severe cerebrovascular disease History of large territory stroke Allergy or sensitivity to B-vitamins or nicotinic acid History of elevated liver function tests (ALT/AST \> 2x the upper limit of normal) or known liver disease Current consumption of Vitamin B3 (any form, including nicotinic acid) - including multivitamins and energy drinks. Participants taking a supplement containing Niacin must washout for 4 weeks prior to screening to participate. Renal impairment of Stage 2 or greater
Where this trial is running
Indianapolis, Indiana
- IU Health Neuroscience Center — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Jared R Brosch, MD — Indiana University
- Study coordinator: Jared R Brosch, MD
- Email: jbrosch@iu.edu
- Phone: 317-274-4455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.