Nicotinic Acid for the Treatment of Alzheimer's Disease
Indiana University
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.
Description
Alzheimer's disease (AD) is a highly prevalent neurodegenerative disorder with several modestly effective therapies. Interestingly, increased dietary intake of niacin is correlated with reduced risk of AD and age-associated cognitive decline. Niacin/nicotinic acid is obtained principally through diet and can cross the blood brain barrier. Overall data support that niacin can be beneficial at mid/late AD stages limiting both amyloid and tau pathologies. Niacin formulations are currently being tested in clinical trials for Parkinson's disease and glioblastoma (NCT04677049 and NCT03808961) and ar…
Eligibility
- Age range
- 60–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 Criteria: Any contraindicatio…
Interventions
- DrugPlacebo Comparator
a readily available inert placebo will be used
- DrugExtended Release Niacin
500 mg
Location
- IU Health Neuroscience CenterIndianapolis, Indiana