NCT06582706 Nicotinic Acid for the Treatment of Alzheimer's Disease
| NCT ID | NCT06582706 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Indiana University |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-12-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jared R Brosch, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06582706 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06582706 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06582706 currently recruiting?
Yes, NCT06582706 is actively recruiting participants. Contact the research team at jbrosch@iu.edu for enrollment information.
Where is the NCT06582706 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06582706 clinical trial?
NCT06582706 is sponsored by Indiana University. The principal investigator is Jared R Brosch, MD at Indiana University. The trial plans to enroll 30 participants.
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