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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00736996 |
The purpose of this study is to investigate novel treatments to delay progression to dementia in patients 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. This study will also discover potential mechanisms for the improvements and determine the baseline prevalence of amnestic versus non-amnestic MCI.
Condition | Intervention | Phase |
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Mild Cognitive Impairment |
Drug: Pioglitazone Drug: Placebo Behavioral: Endurance Exercise Training (EET) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Pioglitazone and Exercise Effects on Older Adults With MCI and Metabolic Syndrome |
Estimated Enrollment: | 300 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pioglitazone: Experimental |
Drug: Pioglitazone
30 - 45mg tablet daily for 6 months
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EET: Active Comparator |
Behavioral: Endurance Exercise Training (EET)
Individualized exercise prescription, 45-75 minutes (progressive increments) three times a week
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Placebo: Placebo Comparator |
Drug: Placebo
Matching tablet daily for 6 months
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The Metabolic Syndrome (MS) is a rapidly growing public health problem. This constellation of metabolic abnormalities increases the risk of diabetes, heart disease and death. Recently evidence has linked MS with cognitive impairment and dementia, including Alzheimer's Disease (AD). AD is preceded by a state called Mild Cognitive Impairment (MCI), characterized by subjective and objective memory impairment, but no functional impairment. Although not all persons with MCI will develop AD, the conversion rate from MCI to AD is about 15% per year, or 5-10 times that of cognitively normal individuals. There is great interest in finding treatments to prevent AD by intervening at an earlier stage, i.e. MCI.
The mechanism(s) linking MS and cognitive impairment are not clear, although there is evidence that insulin resistance and inflammation play key roles. Thiazolidinediones (TZDs) are medications approved for the treatment of Type 2 Diabetes, which work by reducing insulin resistance. In addition, these drugs have anti-inflammatory properties. A recent pilot study showed improvements in some areas of cognition in patients with MCI or mild AD treated with the TZD rosiglitazone. Endurance exercise training (EET) is an established treatment for MS and insulin resistance. There is also evidence that EET may improve cognitive function as well.
Adults aged 55 years or older with both MS and MCI at baseline will be randomized to a 6-month intervention with either (1) treatment with pioglitazone, (2) endurance exercise training, or (3) control (placebo and no exercise). The hypothesis is that treatment with the TZD pioglitazone or EET will improve cognitive function compared to controls, as evidenced by either improvement, stabilization, or lesser decline in performance on cognitive testing. Participants will undergo a physical exam including blood and urine tests, a complete neurologic exam, and a comprehensive battery of cognitive tests. They will also have a DEXA scan, exercise treadmill test, non-invasive tests of vascular function and a hyperglycemic-euglycemic clamp procedure to measure insulin resistance.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Must meet 3 of the 5 requirements for Metabolic Syndrome:
Exclusion Criteria:
Contact: Erica Borresen, BS | 720-848-6376 | erica.borresen@uchsc.edu |
United States, Colorado | |
University of Colorado, Denver | Recruiting |
Denver, Colorado, United States, 80045 | |
Contact: Erica Borresen 720-848-6376 erica.borresen@uchsc.edu | |
Principal Investigator: Robert S. Schwartz, MD |
Principal Investigator: | Robert S. Schwartz, MD | University of Colorado Denver |
Responsible Party: | University of Colorado, Denver ( Robert S. Schwartz, M.D., Director, Center on Aging UCD (Anschutz Medical Campus) ) |
Study ID Numbers: | IA0137, R01 AG 028746 |
Study First Received: | August 14, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00736996 |
Health Authority: | United States: Federal Government |
Metabolic Syndrome |
Delirium, Dementia, Amnestic, Cognitive Disorders Pioglitazone Mental Disorders |
Dementia Cognition Disorders Delirium |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |