Metformin in Amnestic Mild Cognitive Impairment (MCI)
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ClinicalTrials.gov Identifier: NCT00620191 |
Recruitment Status
:
Completed
First Posted
: February 21, 2008
Last Update Posted
: March 14, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amnestic Mild Cognitive Impairment | Drug: metformin Drug: placebo | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Metformin in the Prevention of Alzheimer's Disease |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: P
placebo identical to metformin.
|
Drug: placebo
placebo identical to metformin 2 tablets twice a day titrated from one table once a day
|
Experimental: metformin
metformin 1000 mg twice a day
|
Drug: metformin
metformin 1000 mg twice a day titrated from 500 mg once a day
Other Name: glucophage
|
- Total Recall in the Selective Reminding Test [ Time Frame: 12 MONTHS ]
- ADAS-cog [ Time Frame: 12 months ]Alzheimer's Disease Assessment Scale-cognitive subscale
- rCMRgl in the posterior cingulate-precuneus. [ Time Frame: 12 months ]Change in relative glucose uptake (rCMRgl) in the posterior cingulate-precuneus measured with subscale (ADAS-Cog). The secondary outcome was brain [18]F-labeled 2-deoxy-2-fluoro-D-glucose (FDG) positron emission tomography (PET).
- Plasma Amyloid beta-42 [ Time Frame: 12 months ]

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Ages Eligible for Study: | 55 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age range: 55 to 90 years;
- Sex distribution: men and women;
- Languages: fluent in English or Spanish.
-
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:
- less than or equal to 8 for 16 or more years of education.;
- less than or equal to 4 for 8-15 years of education;
- less than or equal to 2 for 0-7 years of education.
- Global Clinical dementia rating (CDR) score must be 0.5 at screening. The memory box score must be 0.5 or 1.0, with no more than two box scores other than memory rated as high as 1.0 and no box score rated greater than 1.0.
- Subjects without a known history of diabetes or diabetes that has never been treated with medications. If diabetes is diagnosed during screening or they have a history of diabetes not treated in the last 12 months they will be excluded if their HbA1c is > 6.5.
- BMI ≥ 25 kg/m2
- No contraindications to metformin treatment.
- General cognition and functional performance such that a diagnosis of dementia cannot be made at the time of screening based on DSM-IV criteria.
- Vision and hearing must be sufficient for compliance with testing procedures.
Exclusion Criteria:
- Subjects with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg;
- Subjects with a history of active cancer or cancer within last five years, with the exception of squamous or basal cell carcinoma of the skin;
- Subjects who for any reason may not complete the study as judged by the study physician;
- Abnormal TSH, B12, and RPR.
- Contraindications to metformin use include a creatinine of > 1.5, liver disease by history or by elevated transaminases, congestive heart failure, and alcohol abuse.
- We will also exclude subjects with a history of intolerance to metformin.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620191
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Jose A Luchsinger, MD | Columbia University |
Publications:
Responsible Party: | José A. Luchsinger, Associate Professor of Medicine and Epidemiology at NYPH/CUMC, Columbia University |
ClinicalTrials.gov Identifier: | NCT00620191 History of Changes |
Other Study ID Numbers: |
AAAC7231 R0153596 ( Other Grant/Funding Number: NIA ) |
First Posted: | February 21, 2008 Key Record Dates |
Last Update Posted: | March 14, 2013 |
Last Verified: | March 2013 |
Keywords provided by José A. Luchsinger, Columbia University:
metformin mild cognitive impairment alzheimer's disease overweight insulin |
Additional relevant MeSH terms:
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders Metformin Hypoglycemic Agents Physiological Effects of Drugs |