CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00620191
NCT00620191Phase 2Completed

Metformin in the Prevention of Alzheimer's Disease

Columbia University·interventional·Posted Feb 21, 2008·Updated Oct 23, 2020

In Brief

A Phase 2 clinical trial evaluating Metformin and Placebo for Mild Cognitive Impairment. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartJun 1, 2008
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.4 years ago

Interventions

Metformindrug

Metformin 1000 mg twice a day titrated from 500 mg once a day

Placebodrug

Placebo identical to metformin 2 tablets twice a day titrated from one table once a day