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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 | Clinical Trials | Clareo Health

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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

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

NCT02284906•Takeda

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Completed the pivotal AD-4833/TOMM40\_301 study with an adjudicated diagnosis of mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) without ongoing serious adverse events (SAEs) from AD-4833/TOMM40\_301.
•2. Is male or female and is at least 65 years of age at the time of the Baseline Visit.
•3. In the opinion of the investigator, is capable of understanding and complying with the protocol requirements.
•4. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
•5. Must be living independently or in nonmedical residential care.
•6. Has a project partner able to separately consent on his/her own behalf and take part in the study (with the intent to do so as long as the participant is enrolled), providing information on the cognitive, functional, and behavioral status of the participant and assisting with observation of adverse events (AEs) and monitoring of study medication, if needed. Project partners participating in the pivotal AD-4833/TOMM40\_301 study are encouraged to participate in this extension study in this capacity.

Exclusion Criteria

•1. Completed the pivotal AD-4833/TOMM40\_301 study with an adjudicated diagnosis of AD dementia.
•2. Has a current diagnosis of significant psychiatric illness, per Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (including but not limited to major depressive disorder, anxiety disorders) and is in an acute phase/episode, or the participant has a current diagnosis or history of schizophrenia or bipolar disorder.
•3. Has a glycosylated hemoglobin (HbA1c) \>8% at the extension study Baseline Visit or requires treatment with insulin, triple oral antidiabetic therapy or a peroxisome proliferator-activated receptor gamma (PPAR-γ) agonist.
•4. Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal (including s/p gastric bypass surgery), endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
•5. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, pivotal, child, sibling) or may consent under duress.
•6. Is required to take excluded medications.
•7. Has a history of hypersensitivity or allergies to pioglitazone or related compounds.
•8. Had any of the following values at the extension study Baseline Visit:
•1. A serum total bilirubin value \>15 x upper limit of normal (ULN).
•2. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>2 x ULN.
+5 more criteria

Locations (43)

Phoenix, Arizona, United States

Sun City, Arizona, United States

San Diego, California, United States

Delray Beach, Florida, United States

Fort Myers, Florida, United States

Lake Worth, Florida, United States

Melbourne, Florida, United States

Merritt Island, Florida, United States

Port Orange, Florida, United States

St. Petersburg, Florida, United States

Key Dates

Start Date

February 12, 2015

Primary Completion Date

January 31, 2018

Completion Date

May 8, 2018

Last Updated

July 2, 2019

Enrollment

ACTUAL participants

Conditions

Mild Cognitive Impairment Due to Alzheimer's Disease

Interventions

Pioglitazone

DRUG

Placebo

DRUG

A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

NCT05399888

Mild Cognitive Impairment Due to Alzheimer's DiseaseAlzheimer's Disease Dementia

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COMPLETED

Biomarkers of Cognitive Impairment in Blood Cells

NCT05582941

Mild Cognitive Impairment Due to Alzheimer's DiseaseDementia Due to Alzheimer's Disease (Disorder)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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