RecruitingPhase 1Phase 2NCT06582706

Nicotinic Acid for the Treatment of Alzheimer's Disease


Sponsor

Indiana University

Enrollment

30 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether nicotinic acid (a form of vitamin B3) can slow the progression of Alzheimer's disease or improve thinking and memory in people with mild to moderate dementia. Nicotinic acid is inexpensive and widely available, and early research suggests it may support brain cell energy and reduce inflammation. **You may be eligible if...** - You are between 60 and 85 years old (male or female) - You have been diagnosed with Alzheimer's disease in the mild to moderate range - Your score on the Mini Mental Status Exam (MMSE) is between 14 and 24 - You are on a stable dose of Alzheimer's medication (or none) for at least 30 days - You have a caregiver or family member who sees you in person at least 3 days per week **You may NOT be eligible if...** - You have liver disease or a history of liver problems - You have had a recent heart attack or stroke - You are allergic to niacin or related compounds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo Comparator

a readily available inert placebo will be used

DRUGExtended Release Niacin

500 mg


Locations(1)

IU Health Neuroscience Center

Indianapolis, Indiana, United States

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NCT06582706


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