Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537076
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
Status:
RECRUITING
Status Verified Date:
2024-09
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:
AR1005
Brief Summary:
This study is a phase 2a single-center double-blind and randomized clinical trial that evaluates the safety and efficacy of AR1005 administration in 60 patients with cognitive impairment due to Lewy body disease The study evaluates whether the administration of AR1005 in patients with cognitive impairment due to Lewy body disease has the effect of improving cognitive function behavioral psychological symptoms cognitive fluctuations movement brain waves and brain activity
Detailed Description:
60 patients will be randomized into either active or placebo groups 11 Both groups will concurrently receive standard treatment with rivastigmine for 20 weeks
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