Nicotinic Acid for the Treatment of Alzheimer's Disease

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06582706
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo Comparator — DRUG
    a readily available inert placebo will be used
  • Extended Release Niacin — DRUG
    500 mg

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Extended -Release Niacin
    500 mg daily
  • Placebo Comparator: Placebo
    Microcrystalline cellulose tablets

Primary Outcome Measure

Change in nicotinic acid levels in blood and CSF [ Time Frame: Baseline and 60 day visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
IU Health Neuroscience CenterIndianapolisIndiana46202
Sheryl E Lynch, RN
[email protected]
317-963-7378

Find similar trials in Indianapolis, IN

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
IU Health Neuroscience Center· Indianapolis, IN

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