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
Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mild Cognitive Impairment Due to Alzheimer's Disease
Intervention: Pioglitazone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Takeda Official(s) and/or principal investigator(s): Medical Director Clinical Science, Study Director, Affiliation: Takeda
Overall contact: Takeda Study Registration Call Center, Phone: +1-877-825-3327, Email: medicalinformation@tpna.com
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).
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from Extension Study Baseline in Composite Score of a Broad Cognitive Test Battery
Secondary outcome: Time to Diagnosis of Alzheimer's Disease (AD) Dementia
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 is anticipated to enroll approximately 316 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 subjects 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
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
3. Unexplained microscopic/macroscopic hematuria on 2 repeat examinations within 2
weeks.
9. Has a disease or takes medication that, in the opinion of the investigator, could
interfere with the assessments of safety, tolerability, or efficacy, or prevent the
participant from adequately participating in the study or continue for the
anticipated duration of the study.
10. Has received any investigational compound, with the exception of treatment during the
AD-4833/TOMM40_301 study, within 30 days prior to Baseline or 5 half-lives prior to
Baseline or is currently participating in another study that entails the
administration of an investigational or marketed drug, supplement, or intervention
including, but not limited to diet, exercise, lifestyle, or invasive procedure.
11. Has any cancer that has been in remission for less than 2 years from the extension
study Baseline Visit. Participants with basal cell or stage I squamous cell carcinoma
of the skin will be eligible. Participants with current diagnosis of bladder cancer
are not eligible irrespective of the remission status.
12. Has a current diagnosis of macular edema, degeneration or any maculopathy.
13. Has a history or current diagnosis of congestive heart failure (CHF), New York Heart
Association class III-IV.
Locations and Contacts
Takeda Study Registration Call Center, Phone: +1-877-825-3327, Email: medicalinformation@tpna.com
Bristol, Avon, United Kingdom; Recruiting
Orlando, Florida, United States; Recruiting
Port Orange, Florida, United States; Recruiting
Additional Information
Starting date: February 2015
Last updated: March 31, 2015
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