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Nicotinic Acid for the Treatment of Alzheimer's Disease

StatusRecruiting
PhasePhase 1/2
Started2024-12-19
View on ClinicalTrials.gov ↗

Amendment history

2026-03-03
Study Status v5
Primary completion date2026-02→2026-12
Completion date2026-02→2026-12
2025-03-04
Study Status v4
Start dateestimated 2025-01→confirmed 2024-12-19
2025-01-27
Study Status v3
Start date2024-12-11→2025-01
2024-12-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2024-10→2024-12-11
Study sitesdetails revised at 1 of 1 site
2024-09-22
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Completion date2026-08→2026-02
Start date2024-09→2024-10
Study sites0→1
InterventionsExtended Release Niacin (Drug)→Extended Release Niacin (Drug), Placebo Comparator (Drug)
Primary endpoints1 entry, revised
IncreasedChange in nicotinic acid levels in blood and CSF
Study description-684 characters
[...] e chosen to most closely match the other treatment tablets. RandomizationFollowing instructionsrandomization, from RedCapparticipants will designate a participant andreceive their uniquely assigned uniquely identifieddrug bottle which will be given to them at randomization with instructions. At the 30-day visit a pill count will be [...] principal investigator remain blinded throughout the study. We expect aA compliance rate of 85% or better (approximately 9 missed doses over the 60 day period) is expected. Participants and study partners will be instructed to take [...] om the study. Pill count is complete [...]
Study title-21 characters
Nicotinic Acid for the Treatment of Alzheimer's Disease: a Phase 1b/2a Study
2024-08-30
Original filing
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.
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