Actively Recruiting
Nicotinic Acid for the Treatment of Alzheimer's Disease
Led by Indiana University · Updated on 2026-03-05
30
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nicotinic Acid for the Treatment of Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60-85 years, male or female
- Clinically diagnosed with mild to moderate Alzheimer's disease (MMSE between 14 and 24 inclusive)
- On a stable dose of cholinesterase inhibitor and/or memantine for at least 30 days, or not taking these medications
- Have a reliable co-participant with at least 3 days of face-to-face contact per week to ensure medication compliance
- Have a brain MRI or CT scan from within 1 year before screening
You will not qualify if you...
- Any contraindication to lumbar puncture such as increased intracranial pressure, posterior fossa mass, bleeding disorders, use of anticoagulants (except aspirin)
- Severe cerebrovascular disease
- History of large territory stroke
- Allergy or sensitivity to B-vitamins or nicotinic acid
- History of elevated liver enzymes (ALT/AST > 2x upper limit) or known liver disease
- Current use of vitamin B3 supplements, including multivitamins or energy drinks, without a 4-week washout before screening
- Renal impairment stage 2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IU Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
J
Jared R Brosch, MD
CONTACT
S
Sheryl E Lynch, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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