Alzheimer DiseasePhase 1/2NCT06582706
Nicotinic Acid for the Treatment of Alzheimer's Disease
A Phase 1/2 study testing Extended Release Niacin in people with Alzheimer Disease, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Extended Release Niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
Sheryl E Lynch, RN, 317-963-7378, slynch@iu.edu
About this study
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.
Read the 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 of AD and age-associated cognitive decline. Niacin/nicotinic acid is obtained principally through diet and can cross the blood brain barrier. Overall data support that niacin can be beneficial at mid/late AD stages limiting both amyloid and tau pathologies. Niacin formulations are currently being tested in clinical trials for Parkinson's disease and glioblastoma (NCT04677049 and NCT03808961) and are FDA-approved to treat dyslipidemia and its safety profile established in the general population. Thus, we propose a phase 2a clinical trial targeting microglia response by repurposing an FDA-approved formulation of niacin. This study (randomized, placebo controlled, blinded) includes a single intervention arm. The intervention is extended release niacin 500mg. The control/placebo group will use microcrystalline cellulose tablets. The size and shape of the placebo pill will be chosen to most closely match the other treatment tablets.
Following randomization, participants will receive their uniquely assigned drug bottle 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. A compliance rate of 85% or better (approximately 9 missed doses over the 60 day period) is expected. Participants and study partners will be instructed to take their dose at the same time every morning. The pills should not be distributed into pill containers and retained within the study drug bottle. If a dose is missed and it is less than 12 hours from the missed dose, it should be taken immediately, otherwise it will be considered a "missed dose". Missing more than 15% of doses will lead to an early termination from the study. Pill count is completed at the interim visit.
At the screening visit patients will be appropriately screened for inclusion/exclusion criteria. Contraindicated medications will be reviewed. Integrity of the relationship between the participant and study partner will be ascertained; EKG and basic laboratory studies including hepatic function testing and coagulation studies will be reviewed. Physical and Neurologic examination will take place. All criteria will be reviewed, and the inclusion/exclusion criteria will be reviewed again at randomization. At randomization the participant will undergo additional cognitive and functional assessments, additional blood work will be drawn, and a lumbar puncture will be performed to obtain approximately 20 ml of cerebrospinal fluid (CSF). At week 4 a safety assessment and blood draw will take place along with pill counts and recording of adverse events (AEs). The final visit at week 8 will mirror the randomization visit with blood work, CSF collection, and cognitive and functional assessments.
- Conditions
- Alzheimer Disease
- Being tested
- Placebo Comparator, Extended Release Niacin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ComparatorDrug
Also called microcrystalline cellulose tablets
a readily available inert placebo will be used
Extended Release NiacinDrug
500 mg
| Study group | Role | What they receive |
|---|---|---|
| Extended -Release Niacin | Experimental | 500 mg daily Receives: Drug: Extended Release Niacin |
| Placebo | Placebo comparator | Microcrystalline cellulose tablets Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nicotinic acid levels in blood and CSF
Target engagement of HCAR2 in the CNS after treatment with niacin
Measured: Baseline and 60 day visit
Secondary outcomes (1)
Number of participants with treatment related adverse events
Adverse events will be collected throughout the study. Adverse events deemed related to nicotinic acid will be delineated from procedural based adverse events by the PI.
Measured: Baseline to 60 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start19 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Jared Brosch, Indiana University
- Investigators
- Jared R Brosch, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582706
- Sponsor's protocol ID
- 23519
- Status last verified
- Mar 2026
- First submitted
- 30 Aug 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Acid for the Treatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06582706
- Acronym / sponsor ID
- 23519
- Conditions
- Alzheimer Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 of AD and age-associated cognitive decline. Niacin/nicotinic acid is obtained principally through diet and can cross the blood brain barrier. Overall data support that niacin can be beneficial at mid/late AD stages limiting both amyloid and tau pathologies. Niacin formulations are currently being tested in clinical trials for Parkinson's disease and glioblastoma (NCT04677049 and NCT03808961) and are FDA-approved to treat dyslipidemia and its safety profile established in the general population. Thus, we propose a phase 2a clinical trial targeting microglia response by repurposing an FDA-approved formulation of niacin. This study (randomized, placebo controlled, blinded) includes a single intervention arm. The intervention is extended release niacin 500mg. The control/placebo group will use microcrystalline cellulose tablets. The size and shape of the placebo pill will be chosen to most closely match the other treatment tablets.
Following randomization, participants will receive their uniquely assigned drug bottle 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. A compliance rate of 85% or better (approximately 9 missed doses over the 60 day period) is expected. Participants and study partners will be instructed to take their dose at the same time every morning. The pills should not be distributed into pill containers and retained within the study drug bottle. If a dose is missed and it is less than 12 hours from the missed dose, it should be taken immediately, otherwise it will be considered a "missed dose". Missing more than 15% of doses will lead to an early termination from the study. Pill count is completed at the interim visit.
At the screening visit patients will be appropriately screened for inclusion/exclusion criteria. Contraindicated medications will be reviewed. Integrity of the relationship between the participant and study partner will be ascertained; EKG and basic laboratory studies including hepatic function testing and coagulation studies will be reviewed. Physical and Neurologic examination will take place. All criteria will be reviewed, and the inclusion/exclusion criteria will be reviewed again at randomization. At randomization the participant will undergo additional cognitive and functional assessments, additional blood work will be drawn, and a lumbar puncture will be performed to obtain approximately 20 ml of cerebrospinal fluid (CSF). At week 4 a safety assessment and blood draw will take place along with pill counts and recording of adverse events (AEs). The final visit at week 8 will mirror the randomization visit with blood work, CSF collection, and cognitive and functional assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Extended -Release Niacin | Experimental | Drug: Extended Release Niacin500 mg daily |
| Placebo | Placebo comparator | Drug: Placebo ComparatorMicrocrystalline cellulose tablets |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo ComparatorAlso: microcrystalline cellulose tabletsa readily available inert placebo will be used | Drug | Placebo |
| Extended Release Niacin500 mg | Drug | Extended -Release Niacin |
Primary outcome
Change in nicotinic acid levels in blood and CSF
Time frame: Baseline and 60 day visit
Target engagement of HCAR2 in the CNS after treatment with niacin
1 secondary outcome
Number of participants with treatment related adverse events
Time frame: Baseline to 60 day visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jared R Brosch, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Extended Release Niacin in people with Alzheimer Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jared R Brosch, MD (317-274-4455, jbrosch@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nicotinic acid levels in blood and CSF (time frame: Baseline and 60 day visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.