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

Alzheimer Disease

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

Inclusion Criteria5

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

Exclusion Criteria7

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