Nicotinic Acid for the Treatment of Alzheimer's Disease
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 u
| Condition(s) | Alzheimer Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 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 cerebrov |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Lead sponsor | Indiana University |
| Locations | Indianapolis, Indiana, United States |
| Start date | 2024-12-19 |
| NCT ID | NCT06582706 |
| Official listing | https://clinicaltrials.gov/study/NCT06582706 |