Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546995
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Randomized Double-blind Placebo-controlled Pilot Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This study consists of 2 parts Part A and Part B Part A is a single center randomized double-blind placebo-controlled cohort designed to evaluate the safety tolerability and pharmacokinetics PK of NMRA-323511 among healthy elderly
Part B is a multicenter randomized double-blinded placebo-controlled parallel-group cohort to evaluate the safety tolerability and efficacy of NMRA-323511 among adults with Agitation Associated with Dementia due to Alzheimers Disease
Part A consists of a Screening Period up to 28 days a 10-day Treatment Period and a 10- day Follow-up clinic visit after last dose of study treatment
Part B consists of a Screening Period up to 28 days an 8-week Treatment Period and a 10-day Follow-up clinic visit after last dose of study treatment
Part B is a multicenter randomized double-blinded placebo-controlled parallel-group cohort to evaluate the safety tolerability and efficacy of NMRA-323511 among adults with Agitation Associated with Dementia due to Alzheimers Disease
Part A consists of a Screening Period up to 28 days a 10-day Treatment Period and a 10- day Follow-up clinic visit after last dose of study treatment
Part B consists of a Screening Period up to 28 days an 8-week Treatment Period and a 10-day Follow-up clinic visit after last dose of study treatment
Detailed Description:
None
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