Recruiting
Phase 1
Phase 2

Nicotinic Acid

Sponsor:

Indiana University

Code:

NCT06582706

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo Comparator

Extended Release Niacin

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT06582706

Start date

Dec 19, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Extended -Release Niacin

500 mg daily

placebo comparator: Placebo

Microcrystalline cellulose tablets

Interventions

Placebo Comparator

a readily available inert placebo will be used

Extended Release Niacin

500 mg

Primary outcome measure

  • Change in nicotinic acid levels in blood and CSF [ Time Frame: Baseline and 60 day visit ]

Central Contacts and Locations

Central contacts

Jared R Brosch, MD

317-274-4455jbrosch@iu.edu

Sheryl E Lynch, RN

317-963-7378slynch@iu.edu

Locations

IU Health Neuroscience Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sheryl E Lynch, RN

317-963-7378slynch@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-03-05.