Nicotinic Acid for the Treatment of Alzheimer's Disease

NCT06582706 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 23519
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in nicotinic acid levels in blood and CSF

  Target engagement of HCAR2 in the CNS after treatment with niacin

  Baseline and 60 day visit

Secondary Outcomes (1)

• Number of participants with treatment related adverse events

  Baseline to 60 day visit

Study Arms (2)

Extended -Release Niacin

EXPERIMENTAL

500 mg daily

Drug: Extended Release Niacin

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose tablets

Drug: Placebo Comparator

Interventions

Placebo Comparator DRUG

a readily available inert placebo will be used

Also known as: microcrystalline cellulose tablets

Placebo

Extended Release Niacin DRUG

500 mg

Extended -Release Niacin

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Alzheimer's Association: collaborator

Study Sites (1)

IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jared R Brosch, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared R Brosch, MD

CONTACT

317-274-4455; jbrosch@iu.edu

Sheryl E Lynch, RN

CONTACT

317-963-7378; slynch@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The size and shape of the placebo pill will be chosen to most closely match the other treatment tablets. The drugs will be placed into identical bottles and will be labeled with a unique identifier and stored in a locked, temperature monitored room. Randomization instructions from RedCap will designate a participant and their assigned uniquely identified bottle which will be given to them at randomization with instructions. At the 30-day visit a pill count will be undertaken to reinforce compliance. The bottle and any remaining pills will be collected at the end of the study and compliance will be assessed. All pill counts and pill instructions will be given by a separate study coordinator (due to inability to have a perfectly matching placebo) so that primary study coordinator and principal investigator remain blinded throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a randomized, placebo controlled, blinded trial that includes a single intervention arm. The intervention is extended release niacin 500mg. The control/placebo group will use microcrystalline cellulose tablets.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)