Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582706
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Nicotinic Acid for the Treatment of Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nicotinic Acid for the Treatment of Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Increased dietary intake of niacin is correlated with reduced risk of Alzheimers 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:
Alzheimers 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 Niacinnicotinic acid is obtained principally through diet and can cross the blood brain barrier Overall data support that niacin can be beneficial at midlate AD stages limiting both amyloid and tau pathologies Niacin formulations are currently being tested in clinical trials for Parkinsons 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 controlplacebo 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 inclusionexclusion 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 inclusionexclusion 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
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 inclusionexclusion 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 inclusionexclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None