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Sponsors and Collaborators: |
Columbia University Institute for the Study of Aging (ISOA) National Institute on Aging (NIA) |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00620191 |
Hyperinsulinemia and type 2 diabetes (T2D) are important potential risk factors for cognitive decline and Alzheimer's disease (AD). Two thirds of the US adult population are at risk for hyperinsulinemia and T2D, and half of the population 85 years and older have AD. Peripheral hyperinsulinemia can impair the clearance of amyloid beta in the brain, the main culprit in AD. Thus, we hypothesize the lowering peripheral insulin in overweight persons with amnestic mild cognitive impairment (AMCI), a transition state between normal cognition and AD, can decrease the risk of cognitive decline and progression to AD. We propose to conduct a phase II double blinded placebo controlled randomized clinical trial of metformin, a safe and effective medication that prevents hyperinsulinemia and diabetes, to test this hypothesis among 80 overweight persons aged 55 to 90 years with AMCI. The main outcome of the study will be changes in performance in a memory test and in a composite score of cognition and function. Another aim is to compare brain imaging on an intention-to-treat basis between the metformin and placebo group mean changes from beginning to end among 40 participants using FDG PET scan and MRI.
Condition | Intervention | Phase |
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Amnestic Mild Cognitive Impairment |
Drug: metformin Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Metformin in the Prevention of Alzheimer's Disease |
Estimated Enrollment: | 40 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P: Placebo Comparator
placebo identical to metformin.
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Drug: placebo
placebo identical to metformin 2 tablets twice a day titrated from one table once a day
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metformin: Experimental
metformin 1000 mg twice a day
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Drug: metformin
metformin 1000 mg twice a day titrated from 500 mg once a day
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Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must score below a pre-determined cut-off score on the logical memory II delayed paragraph recall sub-test of the Wechsler Memory Scale Revised (WMS-R)26:
Exclusion Criteria:
Contact: Jose A Luchsinger, MD | 212-3054730 | jal94@columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Alex R Sierra, BA 212-305-4126 as2903@columbia.edu | |
Contact: Evelyn Arana, MS 646 584 1166 ea2310@columbia.edu | |
Principal Investigator: Jose A Luchsinger, MD |
Principal Investigator: | Jose A Luchsinger, MD | Columbia University Medical Center |
Responsible Party: | Columbia University Medical Center ( Jose Luchsinger ) |
Study ID Numbers: | ISOA270901, AAAC7231 |
Study First Received: | February 7, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00620191 |
Health Authority: | United States: Food and Drug Administration |
metformin mild cognitive impairment alzheimer's disease overweight insulin |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Metformin Alzheimer Disease Central Nervous System Diseases Overweight |
Neurodegenerative Diseases Brain Diseases Dementia Insulin Cognition Disorders Delirium |
Hypoglycemic Agents Physiological Effects of Drugs Nervous System Diseases Tauopathies Pharmacologic Actions |