Nicotinic Acid for the Treatment of Alzheimer's Disease

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06582706

Run by

Indiana University

People needed

30

Starts

2024-12-19

Expected to finish

2026-12-01

Last updated by the study team

2026-03-05

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• IU Health Neuroscience Center — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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