Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 – 85
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for people aged 60-85 with mild to moderate Alzheimer's disease. Participants will take a dose of nicotinic acid and undergo tests to see how it affects their spinal fluid.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 60 and 85 years old.
I have been diagnosed with mild to moderate Alzheimer's disease.
I have a Mini Mental Status Examination (MMSE) score between 14 and 24.
I have been on a stable dose of cholinesterase inhibitor and/or memantine for at least 30 days.
I have a reliable person who can help me with the study.
I have had a brain scan (MRI or CT) within the past year.
You may not be able to join if
I have conditions that prevent me from getting a lumbar puncture.
I have severe cerebrovascular disease.
I have had a stroke that affected a large part of my brain.
I am allergic to B-vitamins or nicotinic acid.
I have had elevated liver function tests or liver disease.
I am currently taking any form of Vitamin B3, including energy drinks.
I have renal impairment of Stage 2 or greater.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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…
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
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