Status:
RECRUITING
Nicotinic Acid for the Treatment of Alzheimer's Disease
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Alzheimer's Association
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE1
PHASE2
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 commerci...
Detailed Description
Alzheimer's disease (AD) is a highly prevalent neurodegenerative disorder with several modestly effective therapies. Interestingly, increased dietary intake of niacin is correlated with reduced risk o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06582706
Start Date
December 19 2024
End Date
February 1 2026
Last Update
March 5 2025
Active Locations (1)
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1
IU Health Neuroscience Center
Indianapolis, Indiana, United States, 46202