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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: Completed Phase 2 study of Mild Cognitive Impairment, sponsored by Columbia University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven i
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-06-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00620191 record still lists
NCT00620191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00620191's enrollment target sits among peer trials
80 104th of 205 higher than 97 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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