NCT06582706 · Phase 1 · RECRUITING
Nicotinic Acid for the Treatment of Alzheimer's Disease
This small study gives people with mild-to-moderate Alzheimer's a single 500 mg dose of extended-release niacin (vitamin B3), or a placebo. Researchers measure whether niacin reaches the spinal fluid and blood. They also track safety. It is a Phase 1 trial, an early check on how the body handles it, not proof it works.
Eligibility 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-05