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Vitamin Supplement

Niacin for Alzheimer's Disease

Phase 1 & 2
Recruiting
Led By Jared R Brosch, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 60-85 males or females
Clinically diagnosed with Alzheimer's disease in the mild-moderate dementia range (Mini Mental Status Examination (MMSE) between 14-24 inclusive)
Must not have
Severe cerebrovascular disease
History of large territory stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 60 day visit

Summary

"This trial aims to study the effects of niacin on Alzheimer's Disease and cognitive decline by measuring how niacin enters the spinal fluid. Participants will take a 500 mg dose of niacin or a

Who is the study for?
This trial is for men and women aged 60-85 with mild to moderate Alzheimer's, as shown by a score of 14-24 on the MMSE. Participants must be on a stable dose of Alzheimer's medication or not taking any, have someone who sees them at least three times a week to help with medicine, and recent brain scans.
What is being tested?
The study tests if extended-release niacin (vitamin B3) can reach the brain after being taken orally. It compares niacin against a placebo in increasing its levels in blood and spinal fluid, which might show it engages targets in the central nervous system related to Alzheimer's.
What are the potential side effects?
While specific side effects are not listed here, generally niacin can cause flushing, itching, nausea, and increased blood sugar. The trial will collect data on how well patients tolerate niacin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 60 and 85 years old.
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I have been diagnosed with mild to moderate Alzheimer's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a severe brain blood vessel condition.
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I have had a major stroke before.
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I have had high liver enzyme levels or a known liver disease.
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My kidney function is reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 60 day visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 60 day visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in nicotinic acid levels in blood and CSF
Secondary study objectives
Number of participants with treatment related adverse events

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Extended -Release NiacinExperimental Treatment1 Intervention
500 mg daily
Group II: PlaceboPlacebo Group1 Intervention
Microcrystalline cellulose tablets

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,854 Total Patients Enrolled
Alzheimer's AssociationOTHER
99 Previous Clinical Trials
43,414 Total Patients Enrolled
Jared R Brosch, MDPrincipal InvestigatorIndiana University
~20 spots leftby Feb 2026
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