NCT02284906

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment Due to Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Pioglitazone	Pioglitazone tablets
DRUG	Placebo	Pioglitazone placebo-matching tablets

Timeline

• Start date: 2015-02-12
• Primary completion: 2018-01-31
• Completion: 2018-05-08
• First posted: 2014-11-06
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

43 sites across 4 countries: United States, Australia, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study