Clinical Trial

Nicotinic Acid for the Treatment of Alzheimer's Disease

Recruiting Phase 1/2
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Summary
Increased dietary intake of niacin is correlated with reduced risk of Alzheimer's Disease and age-associated cognitive decline. The goal of this study is to collect data on the penetration of commercially available, FDA approved, extended-release niacin into the spinal fluid. One dose of 500 mg nicotinic acid will be used (in addition to placebo) to build a dose response curve for this compound in human cerebrospinal fluid. This objective will demonstrate target engagement of HCAR2 in the central nervous system, after oral treatment with niacin. The primary endpoints are to show increased nicotinic acid levels in blood and cerebrospinal fluid. A secondary endpoint is to collect safety and tolerability data of niacin in this particular population.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-08-30; most recent amendment 2026-03-03.
Status change: Not Yet Recruiting → Recruiting 2024-12-10
Trial Details
NCT Number NCT06582706
Lead Sponsor Indiana University
Collaborators: Alzheimer's Association
Conditions Alzheimer Disease
Enrollment 30 participants
Start Date 2024-12-19
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-05