Nicotinic Acid for the Treatment of Alzheimer's Disease
About this study
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.
- Condition
- Alzheimer Disease
- Tested
- Placebo Comparator, Extended Release Niacin
- Sponsor
- Indiana University
Who can join
- Age
- 60 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 60 years
- Maximum age: 85 years
- Study condition: Alzheimer Disease
- 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 7
- 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
1 site, 1 recruiting
IU Health Neuroscience Center
Indianapolis, Indiana, United States
Contact
-
Jared R Brosch, MD
317-274-4455 jbrosch@iu.edu
-
Sheryl E Lynch, RN
317-963-7378 slynch@iu.edu
Potential match only. Final eligibility is determined by the study team.