Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804241
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2021-03-07
Brief Title:
Senicapoc in Alzheimers Disease
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Proof of Mechanism Study of Senicapoc in Mild or Prodromal Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Senicapoc
Brief Summary:
Development of novel disease-modifying therapies for Alzheimers disease AD remains of paramount importance This study will be a Phase II randomized clinical trial testing Senicapoc in patients with mild or prodromal AD This will be a small Proof of Mechanism study to prove biological activity and target engagement in humans with early AD The investigators will study up to 55 patients over 52 weeks with primary outcomes being Alzheimers Disease Assessment Scale Cognitive Subscale ADAS-Cog scores and blood and cerebrospinal fluid CSF markers of neuroinflammation This pilot study will provide an estimate of treatment effect size on cognitive trajectory daily function and brain atrophy
Detailed Description:
The investigators will study up to 55 patients 83 active treatment with 10 mgday maintenance dose placebo over 52 weeks in either the Sacramento or East Bay locations the University of California Davis Alzheimers Disease Research Center ADRC with cognitive outcomes blood and CSF markers of neuroinflammation This pilot study will provide an estimate of treatment effect size on cognitive trajectory daily function and brain atrophy The trial will last 1 year 52 weeks on 10 mgday of active drug or placebo with primary efficacy measures at baseline week 26 and week 52 Additional safety monitoring visits will occur at weeks 4 12 and 36 including physical exams measurement of blood pressure vital signs safety labs electrocardiogram recordings collection of Adverse Events and Concomitant Medications The study will culminate with a visit at 78 weeks 26 weeks after last dose allowing full wash-out from the central nervous system CNS to test if the previously treated and untreated groups show any differences as would be expected if Senicapoc treatment for 1 year was disease-modifying All participants will be required to participate in either the CSF Sub-study or the Amyloid Positron Emission Tomography PET Sub-study All participants will be required to participate in the Cognitive Event Related Potential ERP Sub-study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None