Using niacin to treat Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate the effects of extended-release niacin on patients with Alzheimer's disease by measuring its penetration into the cerebrospinal fluid. Participants aged 60-85 with mild to moderate dementia will receive either niacin or a placebo in a randomized, double-blind manner. The study will assess the levels of nicotinic acid in blood and cerebrospinal fluid, as well as the safety and tolerability of niacin. The goal is to establish a dose-response curve and evaluate the potential benefits of niacin in targeting neurodegenerative processes associated with Alzheimer's.

Why it matters

Who can join: the full rules

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

Where it's running

• IU Health Neuroscience Center
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Jared R Brosch, MD — Indiana University
• Study coordinator: Jared R Brosch, MD
• Email: jbrosch@iu.edu
• Phone: 317-274-4455

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.