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NCT00620191 · ClinicalTrials.gov registry record · Phase 2

Metformin in Amnestic Mild Cognitive Impairment

A Phase 2 study of Mild Cognitive Impairment, sponsored by Columbia University.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target
1
Study location

NCT00620191 is a Phase 2 study of Mild Cognitive Impairment that has completed, run by Columbia University. The registered enrollment target is 80 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00620191, a Phase 2 study of Mild Cognitive Impairment, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

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, the investigators hypothesize that 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. The investigators 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 (total recall of the Selective Reminding Test) and the Score a test of general cognitive function used in clinical trials (the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)). Another aim is to compare brain function in an area affected by Alzheimer's disease between the metformin and placebo group mean changes from beginning to end among 40 participants using a PET scan.

Conditions Studied

Mild Cognitive Impairment

Interventions

  • DRUG Placebo
  • DRUG Metformin

Study Locations (1)

New York

  • Columbia University Medical Center - New York

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2008-06-01
Est. Completion 2012-02
Phase Phase 2

Sponsor

Columbia University

958 total trials

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What the Registry Record Tells You About NCT00620191

The ClinicalTrials.gov registry entry for NCT00620191 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (94% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00620191 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00620191 about?

NCT00620191 is a clinical study titled "Metformin in Amnestic Mild Cognitive Impairment". 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 i...

What is the current status of trial NCT00620191?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-06-01. Estimated completion is 2012-02.

What conditions does trial NCT00620191 study?

This clinical trial studies the following conditions: Mild Cognitive Impairment.

What interventions are being tested in trial NCT00620191?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).

Who is sponsoring clinical trial NCT00620191?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00620191 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.