[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06582706":3,"trial-entities:NCT06582706":89,"trial-summary:NCT06582706":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":84,"references":87,"see_also_links":88},"NCT06582706","23519","Nicotinic Acid for the Treatment of Alzheimer's Disease","RECRUITING","2026-12","2026-03","2026-03-05","2024-12-19","Indiana University","OTHER",false,"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.","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\u002Fnicotinic acid is obtained principally through diet and can cross the blood brain barrier. Overall data support that niacin can be beneficial at mid\u002Flate 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\u002Fplacebo 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.\n\nFollowing 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.\n\nAt the screening visit patients will be appropriately screened for inclusion\u002Fexclusion 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\u002Fexclusion 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.",[18],"Alzheimer Disease",[],"INTERVENTIONAL","TREATMENT",[23,24],"PHASE1","PHASE2",{"count":26,"type":27},30,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Placebo Comparator","a readily available inert placebo will be used",[34],"Placebo",[36],"microcrystalline cellulose tablets",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Extended Release Niacin","500 mg",[41],"Extended -Release Niacin",[43],{"measure":44,"description":45,"timeFrame":46},"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",[48],{"measure":49,"description":50,"timeFrame":51},"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.","Baseline to 60 day visit","ALL","60 Years","85 Years",{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\nAge 60-85 males or females\n\nClinically have a diagnosis of Alzheimer's disease in the mild-moderate dementia range Mini Mental Status Examination (MMSE) between 14-24 inclusive\n\nMust be on a stable dose (30 days minimum) of a cholinesterase inhibitor and\u002For memantine (or absence thereof)\n\nHave 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.\n\nNeuroimaging (MRI or CT scan of the brain) should be available within 1 year of screening\n\nExclusion Criteria:\n\nAny 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\n\nSevere cerebrovascular disease\n\nHistory of large territory stroke\n\nAllergy or sensitivity to B-vitamins or nicotinic acid\n\nHistory of elevated liver function tests (ALT\u002FAST \\> 2x the upper limit of normal) or known liver disease\n\nCurrent 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.\n\nRenal impairment of Stage 2 or greater",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"IU Health Neuroscience Center","Indianapolis","Indiana","46202","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Sheryl E Lynch, RN","CONTACT","317-963-7378","slynch@iu.edu",{"lat":76,"lon":77},39.76838,-86.15804,[79,83],{"name":80,"role":72,"phone":81,"email":82},"Jared R Brosch, MD","317-274-4455","jbrosch@iu.edu",{"name":71,"role":72,"phone":73,"email":74},[85],{"name":80,"affiliation":12,"role":86},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Alzheimer's Disease",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is a randomized, placebo-controlled, and blinded study involving 30 participants. It compares extended-release niacin (500 mg) to an inactive placebo.","completed","Nicotinic Acid for Alzheimer's Disease","This study is looking into whether extended-release niacin, an FDA-approved medication, can reach the brain and spinal fluid in people with mild to moderate Alzheimer's disease. Researchers want to see if niacin levels increase in your blood and spinal fluid after taking a 500 mg dose. You might receive either extended-release niacin or an inactive placebo. The study is enrolling 30 participants, aged 60 to 85, who have a diagnosis of Alzheimer's disease and are on a stable dose of other Alzheimer's medications. You also need a reliable co-participant who sees you at least three days a week. This research aims to understand if niacin could be a new way to help treat Alzheimer's.","Your nicotinic acid levels will be measured at baseline and at the 60-day visit.",114,"Participants will have visits at baseline and at 60 days. Pill counts will be done at the 30-day visit to check that you are taking the medication as instructed.","Not stated in the trial record.",[],"v2"]