Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-02-28 @ 10:03 PM
Study NCT ID:
NCT02284906
Status:
TERMINATED
Last Update Posted:
2019-07-02
First Post:
2014-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AD-4833/TOMM40_303 Extension Study of the Safety and Efficacy of Pioglitazone to Slow Cognitive Decline in Participants With Mild Cognitive Impairment Due to Alzheimer Disease
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Blinded Long-term Extension Study to Evaluate the Safety and Efficacy of Pioglitazone (AD-4833 Sustained Release 0.8 mg Daily) to Slow the Progression of Cognitive Decline in Subjects Who Have Completed the AD-4833/TOMM40_301 Study With Diagnosis of Mild Cognitive Impairment Due to Alzheimer Disease
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy of the drug; no safety concern
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 study is to evaluate the effect of pioglitazone at 24 months compared with placebo on cognitive decline in high-risk participants who have completed the AD-4833/TOMM40\_301 study \[NCT01931566\] with an adjudicated diagnosis of mild cognitive impairment (MCI) due to Alzheimer's Disease (AD).
Detailed Description:
The drug being tested in this study is called pioglitazone. This study is designed to further evaluate the safety and effectiveness of pioglitazone on cognitive function in participants who have completed the AD-4833/TOMM40\_301. This study will look at the effectiveness of pioglitazone on cognitive decline in high-risk participants who have completed the AD-4833/TOMM40\_301 study with a diagnosis of mild cognitive impairment (MCI) due to Alzheimer's Disease (AD).
The study enrolled 40 participants, but is dependent on how many decide to continue treatment in an extension phase after completing the main (301) study. Participants will continue to receive the same study medication they received during the pivotal AD-4833/TOMM40\_301 study, either:
* Pioglitazone 0.8 mg tablets or
* Placebo (this is a tablet that looks like the study drug but has no active ingredient).
All participants will be asked to take one tablet at the same time each day throughout the study.
This multi-centre trial, like its precedent pivotal trial, will be conducted worldwide. The overall time to participate in this study is minimum 2 years and a maximum of 7 years depending on when participants roll over from the 301 study. Participants will make approximately 2 visits per year to the clinic, and will be contacted by telephone 3 months after each treatment visit for a follow-up assessment, and 2 weeks after the final visit.
The study enrolled 40 participants, but is dependent on how many decide to continue treatment in an extension phase after completing the main (301) study. Participants will continue to receive the same study medication they received during the pivotal AD-4833/TOMM40\_301 study, either:
* Pioglitazone 0.8 mg tablets or
* Placebo (this is a tablet that looks like the study drug but has no active ingredient).
All participants will be asked to take one tablet at the same time each day throughout the study.
This multi-centre trial, like its precedent pivotal trial, will be conducted worldwide. The overall time to participate in this study is minimum 2 years and a maximum of 7 years depending on when participants roll over from the 301 study. Participants will make approximately 2 visits per year to the clinic, and will be contacted by telephone 3 months after each treatment visit for a follow-up assessment, and 2 weeks after the final visit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: