Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05267535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-02-22
Brief Title:
Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimers Disease
Sponsor:
Neurim Pharmaceuticals Ltd
Organization:
Neurim Pharmaceuticals Ltd
Study Overview
Official Title:
Randomized Delayed Start Double Blind Parallel Group Placebo Controlled Multicenter Study of Piromelatine 20 mg in Participants With Mild Dementia Due to Alzheimers Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
Randomized efficacy and safety study of piromelatine 20 mg versus placebo in participants with mild dementia due to Alzheimers disease AD who are 2107510000-107540000 polymorphism non-carriers with the primary objective to compare the effect of piromelatine to that of placebo on the AD Assessment Scale cognitive subscale ADAS-cog14 at Week 26 of double-blind treatment
Detailed Description:
This study of piromelatine 20 mg versus placebo in participants with mild dementia due to Alzheimers disease is conducted as a confirmatory randomized efficacy and safety study in participants who are 2107510000-107540000 polymorphism non-carriers N225 Participants will be randomized in a 11 allocation ratio to receive either piromelatine 20 mg or placebo for 26 weeks Medication is to be administered orally one tablet daily taken 1-2 hours before going to bed preferably between 2100h and 2200h and after food
To differentiate between symptomatic effects and potential disease modifying effects of piromelatine there will be a delayed-start open-label extension period of 12 months treatment wherein placebo-treated participants will be treated with piromelatine 20 mg daily and the piromelatine-treated patients will be continued This exploratory phase is aimed to continue randomized assignment of piromelatine treatment long-term 18 months overall to evaluate its potential disease modifying effect compared to patients in the placebo-randomized group who started the treatment after a 6-month delay
The primary efficacy analysis blinded is planned after completion of the 26 weeks double blind period If efficacy is not confirmed then the study will be ended without completing the extension period
To differentiate between symptomatic effects and potential disease modifying effects of piromelatine there will be a delayed-start open-label extension period of 12 months treatment wherein placebo-treated participants will be treated with piromelatine 20 mg daily and the piromelatine-treated patients will be continued This exploratory phase is aimed to continue randomized assignment of piromelatine treatment long-term 18 months overall to evaluate its potential disease modifying effect compared to patients in the placebo-randomized group who started the treatment after a 6-month delay
The primary efficacy analysis blinded is planned after completion of the 26 weeks double blind period If efficacy is not confirmed then the study will be ended without completing the extension period
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?:
None
Is an FDA AA801 Violation?:
None