Ignite Creation Date:
2024-05-06 @ 1:36 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01852110
Status:
TERMINATED
Last Update Posted:
2018-09-18
First Post:
2013-05-08
Brief Title:
Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimers Disease MK-7622-012
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Seamless Phase IIaIIb Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Trial to Evaluate the Efficacy and Safety of MK-7622 as an Adjunctive Therapy for Symptomatic Treatment in Subjects With Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stage 1 interim analysis of efficacy met the criteria for early trial termination futility The trial was terminated at Stage 1 did not proceed to Stage 2
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this multicenter trial is to assess the efficacy and safety of MK-7622 compared with placebo as adjunctive therapy to acetylcholinesterase inhibitors AChEIs for the symptomatic treatment of participants with mild to moderate Alzheimers Disease AD The trial consists of two stages Stage 1 and Stage 2 In Stage 1 participants will be randomized to receive either placebo or MK-7622 45 mg once daily In Stage 2 participants will be randomized to receive either placebo or MK-7622 dose 5 15 or 45 mg once daily Participants will be enrolled in only one stage the duration of each stage is approximately 26 weeks Interim analyses will be performed in both Stage 1 and Stage 2 to determine whether the trial should continue The primary study hypotheses are the following Stage 1 - MK-7622 45 mg once daily is superior to placebo with respect to improving cognition in participants with mild to moderate AD as assessed by mean change from baseline in the 11-item Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 at Week 12 Stage 2 - At least one of the top two doses of MK-7622 15 mg once daily 45 mg once daily is superior to placebo with respect to improving cognition in participants with mild to moderate AD as assessed by mean change from baseline in ADAS-Cog11 at Week 12
Detailed Description:
If the double-blind treatment dose is not tolerated during the first 2 weeks the participant will be discontinued After the first 2 weeks if the dose is not tolerated the regimen may be modified according to a defined algorithm Specifically the participant will begin administration of a reduced dose for up to 2 weeks followed by a re-challenge at the original dose only if tolerability issues diminish or resolve at the reduced dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-7622-012 | OTHER | Merck Protocol Number | None |
| 2013-000937-11 | EUDRACT_NUMBER | None | None |