NCT00982202

Pioglitazone in Alzheimer Disease

Pioglitazone in Alzheimer Disease Progression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to assess the safety and tolerability of pioglitazone, an approved drug for type 2 diabetes, in non diabetic patients with Alzheimer's disease. It was also designed to generate preliminary information on whether pioglitazone might slow progression of Alzheimer's disease.

Detailed description

Inflammatory processes are important in the progressive loss of memory and thinking skills in Alzheimer's disease (AD). Laboratory studies show that drugs that bind to a protein known as "Peroxisome Proliferator Activated Receptor-gamma (PPARgamma)" act to reduce inflammatory responses in brain cells known as microglia when they are exposed to amyloid peptide, a major part of AD pathology. Therefore, drugs that activate PPARgamma have great potential for reducing the progression of AD. Pioglitazone (PGZ) activates PPARgamma and has shown favorable clinical experiences and safety profiles in patients with diabetes. This is a pilot study to determine the safety and tolerability of PGZ in patients with AD. Another goal of the study is to assess how clinical measures of cognition, daily function, and behavior might respond to PGZ treatment.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	pioglitazone	15mg tablet daily, increase by one pill at one-week intervals based on reported tolerability; maintain best tolerated dose (1 to 3 tablets daily) for \~18months
DRUG	Placebo	1 to 3 tablets daily for \~18 months

Timeline

• Start date: 2002-01-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2009-09-23
• Last updated: 2009-09-23

Locations

2 sites across 1 country: United States