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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

NCT02284906 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-02

Study results available
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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).

Conditions

  • Mild Cognitive Impairment Due to Alzheimer's Disease

Interventions

DRUG

Pioglitazone

Pioglitazone tablets

DRUG

Placebo

Pioglitazone placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-12
Primary Completion
2018-01-31
Completion
2018-05-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02284906 on ClinicalTrials.gov