Nicotinic Acid for the Treatment of Alzheimer's 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.

Interventions

• Placebo Comparator · DRUG

  a readily available inert placebo will be used

• Extended Release Niacin · DRUG

  500 mg

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 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

Sites (1)

• IU Health Neuroscience Center, Indianapolis, Indiana · RECRUITING