AD-4833/TOMM40_303 Extension Study of the Safety and Efficacy of Pioglitazone to Slow Cognitive Decline in Subjects With Mild Cognitive Impairment Due to Alzheimer Disease
- Conditions
- Mild cognitive impairment due to Alzheimer’s diseaseMedDRA version: 18.0 Level: LLT Classification code 10009846 Term: Cognitive impairment System Organ Class: 100000004852Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2013-004984-30-GB
- Lead Sponsor
- Takeda Development Centre Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1. The subject completed the pivotal AD-4833/TOMM40_301 study with an adjudicated diagnosis of MCI due to AD without ongoing serious adverse events from study AD-4833/TOMM40_301.
2. The subject must be living independently or in nonmedical residential care.
3. The subject 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 subject is enrolled), providing information on the cognitive, functional, and behavioral status of the subject (and self reported, if voluntarily agreed to) and assisting with observation of adverse events 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.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 149
1. The subject completed the pivotal AD-4833/TOMM40_301 study with a diagnosis of AD dementia.
2. The subject 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 subject has a current diagnosis or history of schizophrenia or bipolar disorder.
3. The subject has a glycosylated hemoglobin >8% at the extension study Baseline Visit or requires treatment with insulin, triple oral antidiabetic therapy, or a peroxisome proliferator-activated receptor-gamma agonist.
4. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal (including s/p gastric bypass), endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
5. The subject is required to take excluded medications as specified in the Excluded Medications Section of the protocol.
6. The subject had any of the following values at the extension study Baseline Visit:
- A serum total bilirubin value >1.5× upper limit of normal (ULN).
- A serum alanine aminotransferase or aspartate aminotransferase value >2×ULN.
- Unexplained microscopic/macroscopic hematuria on one repeat examination within 2 weeks.
7. The subject 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 subject from adequately participating in the study or continue for the anticipated duration of the study.
8. The subject has any cancer that has been in remission for less than 2 years from the extension study Baseline Visit.
9. Subjects with basal cell or stage I squamous cell carcinoma of the skin will be eligible. Subjects with current diagnosis of bladder cancer are not eligible irrespective of the remission status.
10. The subject has a current diagnosis of macular edema or macular degeneration.
11. The subject has a history or current diagnosis of congestive heart failure, New York Heart Association class III-IV.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of pioglitazone at 24 months compared with placebo on cognitive decline in subjects who have completed the AD-4833/TOMM40_301 study with an MCI due to AD diagnosis.;Secondary Objective: To evaluate the effect of pioglitazone compared with placebo on the delay of onset of AD dementia in high-risk study subjects.;Primary end point(s): Change from extension study Baseline to 24 months on the composite score of a broad cognitive test battery.;Timepoint(s) of evaluation of this end point: 24 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time to diagnosis of AD dementia.;Timepoint(s) of evaluation of this end point: Change from baseline to event which could occur at any time during the study.