Mild Cognitive Impairment Clinical Trial
Official title:
Pioglitazone and Exercise Effects on Older Adults With MCI and Metabolic Syndrome
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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