Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying its Onset

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 3494

Inclusion Criteria

1. Male or postmenopausal female subject between 65 and 83 years of age, inclusive at the time of the screening visit.
2. The subject must be cognitively normal at baseline, scoring as indicated for the following tests:
- Clinical Dementia Rating (CDR)=0.
- At least one memory test above -1.5 SD of the demographically corrected normative mean.
3. The subject must score =25 on the Mini Mental Status Examination (MMSE) at the screening visit after the education and age adjustment referenced in Appendix G of the protocol.
4. All subjects require a project partner who can separately complete an Acknowledgment Form on his/her own behalf and take part in the study to provide information on the cognitive, functional, and behavioral status of the subject and to assist with monitoring of study medication, if needed.
5. The subject has the ability and intention to participate in regular study visits, in the opinion of the Investigator.

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 3500

Exclusion Criteria

1. The subject has a current diagnosis or history of any type of cognitive impairment or dementia, or has a current diagnosis or history of neurological/psychiatric disorder or any other diagnosis that significantly affects cognitive performance (eg, mental retardation, organic mental disorder).
2. The subject has a current diagnosis of significant psychiatric illness, per the Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) (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 glycosylated hemoglobin (HbA1c) >8.0% at the time of baseline or requires treatment with insulin, triple oral antidiabetic therapy or a peroxisome proliferator-activated receptor-gamma agonist.
The subject should be on a stable antidiabetic regimen for at least 3 months prior to enrollment.
4. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. History of HIV infection is considered exclusionary for this study.
5.The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse/dependence within 2 years prior to the Screening Visit.
6.The subject has a history or current diagnosis of macular edema or macular degeneration.
7. If female, the subject has a history of postmenopausal fractures with no or minimal trauma (eg, wrist, hip, lumbar or thoracic vertebral fracture).
8. The subject has a history or current diagnosis of congestive heart failure (CHF), New York Heart Association Class III-IV.
9. The subject has been exposed to cognitive tests performed in this study within 6 months prior to the Screening Visit with the exception of the MMSE.
10. The subject’s TOMM40 rs10524523 or APOE genotypes or APOE phenotype are known by the subject or the study staff participating in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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