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Find more clinical trials

Pioglitazone or Exercise to Treat Mild Cognitive Impairment

Start: November 2008
End: December 2013
Enrollment: 300

What Is This Study About?

The purpose of this study is to investigate novel treatments to delay progression to dementia in people with mild cognitive impairment (MCI) and metabolic syndrome (MS). The hypothesis is that treatment with pioglitazone or endurance exercise training will improve, stabilize, or attenuate decline in cognitive function compared to controls.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: N/A

Must have:

++More than age 55 years and community-dwelling++Able to perform a telephone interview ++Able to speak, read, and understand English++Allow statin drug, angiotensin converting enzyme inhibitor (ACE-I), angiotensin II receptor blocker (ARB), non-steroidal anti-inflammatory drug (NSAID), or Vitamin E supplement but must be on a stable dose for at least 2 months++Women must be postmenopausal (no menses for 12 months or more)++Must meet three of the five requirements for Metabolic Syndrome: * Waist measurement: greater than 102 cm for men and 88 cm for women * Fasting hypertriglyceridemia: 150 mg/dl (1.7 mmol/L) or higher * Low HDL cholesterol: less than 40 mg/dl (1.0 mmol/L) for men and 50 mg/dl (1.3 mmol/L) for women * Hypertension: higher than 130 mmHg systolic or 85 mmHg diastolic (average of two seated measurements) or currently using an antihypertensive medication * Elevated (untreated) fasting glucose: 100 mg/dl (5.6 mmol/L) or higher++Meet the study's four-step screening process for MCI (to rule out dementia)

Must NOT have:

++Diagnosis of diabetes mellitus (DM), defined as: fasting blood sugar of 126 or higher, a history of known DM, or treatment with any glucose-lowering medication++Current diagnosis of dementia (or MMSE score of less than 24) or a neurological comorbidity other than MCI that might affect cognition including: large vessel stroke, brain tumor, severe brain injury, multiple sclerosis, or Parkinson's disease++Current diagnosis of depression; major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or cooperate with the protocol++Significant cerebral vascular disease ++Modified Hachinski score greater than 4 ++Pregnant, lactating, or having childbearing potential++Concomitant medications with significant cholinergic or anticholinergic effects or adverse effects on cognition, including: antipsychotics, tricyclic antidepressants, anticonvulsants, sedative/hypnotics, anxiolytics, glucocorticoids (chronic or frequent intermittent), gingko biloba, NMDA receptor antagonists, cholinesterase inhibitors, strongly lipid soluble beta blockers (e.g., propranolol)++Hormone replacement therapy (male or female)++Visual/hearing impairment that would significantly impact the ability to undergo psychometric testing++Significant medical illness or organ failure including hepatic or renal failure, unstable cardiac disease, or life expectancy of less than 18 months++Exercise-limiting conditions including: neuromuscular, joint/bone, cardiovascular, peripheral vascular, cerebrovascular, or pulmonary disease; recent myocardial infarction, pulmonary embolus, significant aortic stenosis; exercise limiting obesity++Untreated B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable)++Uncontrolled hypertension: over 160 mmHg systolic or 100 mmHg diastolic (stable treatment is allowable)++Endurance exercise training more than twice a week for 20 minutes (at a level that produces sweating) consistently during the last 6 months++Unstable weight in the last 6 months++Increased risk for Pio toxicity, including baseline liver dysfunction, hematocrit less than 33% men or 30% women, problematic edema, or congestive heart failure++Stage 5 renal impairment (GFR less than 15 or dialysis)++Participating in another clinical trial

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT00736996

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An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health