NCT06582706RecruitingPhase 1/2
Nicotinic Acid for the Treatment of Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Aug 2024
- Start date
- 19 Dec 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Indiana University
- Diseases
- Alzheimer disease
- NCT number
- NCT06582706
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 19 Dec 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- Renal impairment of Stage 2 or greater
Lab values
- History of elevated liver function tests (ALT/AST \> 2x the upper limit of normal) or known liver disease
Who the study is looking for
- 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
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IU Health Neuroscience Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.